Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
Executive Director, Head of Clinical Supply Planning and Operations SCM Daiichi Sankyo, Inc.Executive Director, Head of Clinical Supply Planning and Operations SCMBasking Ridge, NJ$255,000–$425,000 / yearFull timeAdditionally, as the regional head of DSI (US) CSO, this position will 1) Oversee all the Clinical Supply Operation-related functions in DSI, 2) Ensure alignment between DSI-CSO and TECH Unit sub-functions (Project Lead (CMC), Regulatory Affairs CMC, Process Technology Research, Formulation Technology Research, and Analytical & Quality Evaluation Research), 3) Make the best effort to increase the total performance of the TECH Unit. Responsible for leading all Clinical Supply Operation (CSO)-related activities for oncology and specialty medicine drug candidates from early development to launch and life cycle management of products globally to achieve the business success of Daiichi Sankyo Group and managing the Global-CSO function from Daiichi Sankyo Inc. (DSI).
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Head of Quality Assurance, Drug Product, GMP QA Daiichi Sankyo, Inc.Head of Quality Assurance, Drug Product, GMP QABasking Ridge, NJ$226,275–$377,125 / yearFull timeAs a member of SLT/SMT, the role will provide oversight of manufacturing sites according to the product lifecycle, collaborate with Quality teams to complete PPQ planning and the transition to commercial manufacturing activities for the product portfolio, and provide technical expertise to their team of MSMQs. Resolve issues in internal and external manufacturing site quality performance escalated from MSMQs in collaboration and negotiation with Tech Unit Senior Leaders (L-2 Leaders) and other internal peer groups, and escalate issues to GMQ Head as necessary for resolution and approval.
Director, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
NewAssociate Director, Data Quality & Integrity, Global R&D & PV QA Daiichi Sankyo, Inc.Associate Director, Data Quality & Integrity, Global R&D & PV QABasking Ridge, NJ$153,600–$230,400 / yearFull timeLeadership & Strategy Execution – Lead execution of key elements of the global Data Integrity strategy and ensure alignment across R&D, PV, and MA.Translate strategic objectives into multi‑year roadmaps and annual operating plans for data integrity and computerized systems oversight (business operational data focus).Serve as a senior subject matter expert for data integrity and GxP computerized systems governance, advising leadership on risk‑based prioritization and compliance posture. This role leads cross‑functional initiatives, establishes program‑level oversight frameworks, mentors and develops QA capability, and partners with senior stakeholders to ensure robust data governance, regulatory compliance, and measurable continuous improvement.
VP Professional Services, Study Experience Dassault SystèmesVP Professional Services, Study ExperienceIselin, NJ$216,000–$288,000 / yearCelebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. Experience: A minimum of 15 years of progressive experience in professional services, client services, or clinical operations within the life sciences industry (e.g., at a CRO, eClinical/SaaS vendor, Pharma, or Biotech).
Executive Director, Oncology R&D, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Oncology R&D, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeClinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL) Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects Study strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level Study Outputs: For large-studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level People Management: Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.
NewExecutive Director, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeProvides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.
Research & Development, Scientist 2 YANTRAN LLCResearch & Development, Scientist 2Summit, NJ$30–$35 / yearFull timeWork closely with cross-functional teams, including other R&D functions, Commercial Marketing, Quality Assurance, Regulatory Affairs, and Manufacturing, to achieve project goals. Prepare and maintain detailed documentation for product development processes, including experimental protocols, and technical reports in compliance with Good Documentation Practices (GDP).
Medical Science Liaison (CNS) AtriumMedical Science Liaison (CNS)Jersey City, NJ$140,000–$225,000 / yearThe position centers on establishing trusted scientific partnerships, delivering high-quality scientific exchange, and generating actionable insights to guide medical strategy and clinical readiness. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title.
Associate Director, US Brand Marketing CSL SeqirusAssociate Director, US Brand MarketingSummit, NJ$180,000–$205,000With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .
Regulatory Affairs Manager Actalent IncRegulatory Affairs ManagerNJ$90,000–$115,000 / yearOversee the preparation, review, and maintenance of regulatory documents, including TDS, SDS, allergen and GMO statements, nutritional and natural certifications, Non-GMO Project forms, Kosher and Halal certifications, certificates of origin (COO), Prop 65 documentation, flavor labeling, TTB submissions, and related materials. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Regulatory Affairs Project Manager Colgate-Palmolive CoRegulatory Affairs Project ManagerPiscataway, NJ$124,000–$174,000 / yearEstablished in 1806 as a small soap and candle business in New York City, Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate, Palmolive, Softsoap, Irish Spring, Protex, Sorriso, Kolynos, elmex, Tom's of Maine, Sanex, Ajax, Axion, Soupline, Haci Sakir, Suavitel, PCA SKIN, EltaMD, Filorga and Hello as well as Hill's Science Diet and Hill's Prescription Diet. Colgate-Palmolive is a leading consumer products company that serves hundreds of millions of consumers worldwide with brands and products across four core businesses - Oral Care, Personal Care, Home Care and Pet Nutrition.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesRahway, NJ$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Senior Manager, Regulatory Affairs Quidelortho CorpSenior Manager, Regulatory AffairsNJRemoteThis position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL The Responsibilities Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
NewSenior Regulatory Affairs Specialist - Dairy Flora Food GroupSenior Regulatory Affairs Specialist - DairyHackensack, NJ$105,000–$135,000 / yearWorking closely with R&D, Marketing, Quality, Supply Chain, and Commercial teams, you will interpret complex dairy regulations and translate them into practical business guidance that supports compliant product development, labeling, and consumer communications. In this highly autonomous role, you will serve as the regulatory subject matter expert for dairy products, ensuring compliance while enabling innovation, renovation, and commercialization across North American markets.
Regulatory Affairs Project Manager (Piscataway, NJ, US) Colgate-Palmolive CompanyRegulatory Affairs Project Manager (Piscataway, NJ, US)Piscataway, NJ$124,000–$174,000 / yearRisk Management & Lifecycle Monitoring: Proactively identifies and monitors project risks, developing robust mitigation strategies to protect business continuity and minimize timeline impacts or regulatory penalties. Our journey begins with our people—developing strong talent with diverse backgrounds and perspectives to best serve our consumers around the world and fostering an inclusive environment where everyone feels a true sense of belonging.
Regulatory Affairs Manager F. Hoffmann-La Roche LtdRegulatory Affairs ManagerNJ$106,000–$197,000 / yearYou have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders.
NewSenior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)Bridgewater, NJ$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Senior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k) EssenlixSenior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)Monmouth Junction, New JerseyEssenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic systems, including hematology analyzers and disposable cartridges for complete blood count (CBC) testing. We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development.
NewAssociate Director, Commercial Regulatory Affairs Bristol-Myers Squibb CoAssociate Director, Commercial Regulatory AffairsPrinceton, NJ$173,350–$210,058 / yearResponsibilities include: Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area. Description: The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Senior Manager, Regulatory Affairs Advertising and Promotion SanofiSenior Manager, Regulatory Affairs Advertising and PromotionMorristown, NJ$122,250–$176,583.33 / yearAs the Senior Manager, Regulatory Affairs Advertising and Promotion within our GRA Advertising and Promo Team, you will be responsible for conducting the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns. With some direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, including serving as regulatory lead for product launches.
Senior Regulatory Affairs Program Manager ImmunityBio IncSenior Regulatory Affairs Program ManagerSummit, NJLead the design, planning, and execution of complex, cross-functional regulatory programs and strategic initiatives, establishing integrated project plans, timelines, milestones, deliverables, resource allocation, and proactive risk-mitigation strategies to ensure successful outcomes. ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.
Vice President, Global Regulatory Affairs, Team Lead, Strategy Genmab ASVice President, Global Regulatory Affairs, Team Lead, StrategyPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. The Vice President, Global Regulatory Affairs Strategy is a key leadership role within Global Regulatory Affairs, responsible for managing the regulatory strategy and regulatory deliverables for a portfolio of assets across all stages of development.
Manager, Regulatory Affairs - Cosmetics (Global) Church & Dwight Co IncManager, Regulatory Affairs - Cosmetics (Global)Princeton, NJ$110,900–$157,900 / yearChurch & Dwight is seeking a Manager, Regulatory Affairs - Cosmetics (Global) to serve as the regulatory subject matter expert for cosmetic products and lead regulatory strategy, risk assessment, and execution to enable compliant new product development (NPD), global market entry, and lifecycle maintenance. This role partners closely with R&D, Marketing, Quality, Legal, Supply Chain, and international subsidiaries/distributors to ensure products meet global regulatory requirements while supporting business growth and on-time product launches.
Regulatory Affairs Coordinator Capital HealthRegulatory Affairs CoordinatorPennington, NJ$94,556.80–$124,176 / yearSUMMARY: Reporting to the Manager of Regulatory Affairs, coordinates organization-wide as well as program-specific activities related to the regulatory process and the respective governing bodies, including NJ Department of Health, Centers for Medicare and Medicaid Services (CMS), DNV and others. When determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity.
Regulatory & Clinical Affairs Manager PEAK Technical StaffingRegulatory & Clinical Affairs ManagerPrinceton, NJDesired CharacteristicsCollaborative working style with the ability to build productive relationships across engineering, clinical, quality, and commercial teams. Candidate Privacy To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/and https://peaktechnical.com/ca-residents-privacy-rights/
Regulatory Affairs Manager Hybrid Spectrum VascularRegulatory Affairs Manager HybridBridgewater, NJThis individual serves as a key regulatory lead within cross-functional teams and is accountable for ensuring that regulatory requirements are effectively translated into actionable plans and deliverables across the product lifecycle. This role combines strategic oversight with hands-on regulatory execution, including direct authorship of complex submissions (e.g., 510(k)s), regulatory assessments, and agency interactions.
Specialist, Regulatory Affairs Operations Publishing Taiho OncologySpecialist, Regulatory Affairs Operations PublishingPrinceton, NJ$86,700–$102,000 / yearFull timeThe Regulatory Affairs Operations team creates and manages investigational and marketing applications to health authorities like the FDA and EMA, compiles required data and maintains compliance with evolving regulations and technologies—including AI—to support drug review, approval and market access while protecting public health. Advanced skills in eCTD publishing tools (including docuBridge), MS-Office, Adobe Acrobat applications, electronic document management systems (preferably Generis’ CARA), and the ability to learn required systems and processes quickly.
Regulatory Affairs Senior Director, Project Management Excellence Becton Dickinson and CoRegulatory Affairs Senior Director, Project Management ExcellenceFranklin Lakes, NJ$230,300–$368,500 / yearKnowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs. Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.
Senior Manager, Regulatory Affairs - OTC GSKSenior Manager, Regulatory Affairs - OTCWarren, New JerseyThis role requires building strong relationships with internal and external stakeholders; strategic regulatory decision-making and execution of more complex projects; leadership of cross funtional team and Health Authority interactions, and developing regulatory talent (with or without formal line management responsibilities). Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsMORRISTOWN, NJ$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Regulatory Affairs Senior Director, Digitalization Becton Dickinson and CoRegulatory Affairs Senior Director, DigitalizationFranklin Lakes, NJ$230,300–$368,500 / yearThe Senior Director of Regulatory Affairs, Digitalization, reports to the Vice President of Regulatory Affairs, Regulatory Affairs Management, Enterprise Excellence, and is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions. Lead Strategic Initiative Development: Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy.
Regulatory & Clinical Affairs Manager PEAK Technical Services Inc.Regulatory & Clinical Affairs ManagerPrinceton, NJ$150,000–$185,000 / yearDesired Characteristics Collaborative working style with the ability to build productive relationships across engineering, clinical, quality, and commercial teams. To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/ and https://peaktechnical.com/ca-residents-privacy-rights/ .
Sr Director of Regulatory Affairs - North America Perrigo Co PlcSr Director of Regulatory Affairs - North AmericaMorristown, NJ$225,000–$275,000 / yearLCM & Regulatory Operations owns regulatory classification governance, post-launch lifecycle activities (non-innovation), and operational processes and systems; this role sets market priorities and delivery expectations. Category Regulatory Affairs owns ideation-to-launch strategy, regulatory pathways, and global dossier expectations; this role provides market input and executes the agreed strategy locally.
Director, US Regulatory Affairs - Advertising and Promotion SanofiDirector, US Regulatory Affairs - Advertising and PromotionMorristown, NJ$178,500–$257,833.33 / yearDirector/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen.
Regulatory Affairs Senior Manager LancesoftRegulatory Affairs Senior ManagerWarren, NJJob Purpose: The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle Maintenance for the portfolio of products defined by the US Business Units. Provides advice on US-specific activities and ways of working and processes; Proactively identify potential risks and manage impact of regulatory changes within defined scope of.
Associate Director, Regulatory Affairs Project Planning & Coordination Acadia Pharmaceuticals IncAssociate Director, Regulatory Affairs Project Planning & CoordinationPrinceton, NJ$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Manager, Regulatory Affairs MTF BiologicsManager, Regulatory AffairsEdison, New Jersey$99,000–$125,000 / yearFull timeThis role oversees Regulatory Affairs personnel and ensures effective execution of U.S. and international regulatory activities, including regulatory submissions, inspections and audits, recalls, licensing, labeling and promotional review, quality system documentation, risk management, and design control support. Prior experience handling FDA inspections for medical devices, diagnostics, biologics and/or pharma Demonstrated success in obtaining US FDA regulatory clearance/approval for medical technologies.
Senior Manager, Regulatory Affairs Getinge ABSenior Manager, Regulatory AffairsWayne, NJRemoteThe Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.
Executive Director, Regulatory Affairs Merck & Co IncExecutive Director, Regulatory AffairsNJ$255,800–$402,700 / year10% Travel Required Skills: Antibody Drug Conjugates (ADC), Antibody Drug Conjugates (ADC), Biopharmaceuticals, Biopharmaceutics, Chemistry, Collaborative Development, Confidentiality, Cross-Cultural Awareness, Decision Making, Electronic Common Technical Document (eCTD), Executive Management, Mentoring Staff, People Leadership, Pharmaceutical Sciences, Professional Networking, Project Management, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance Audits, Regulatory Development, Regulatory Monitoring, Regulatory Reporting, Regulatory Risk, Regulatory Submissions, Risk Analysis {+ 2 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Accountable for ensuring successful development and implementation of the global CMC regulatory strategy and for global registration and post approval strategy for new products to meet our company's business needs Leads the team responsible regulatory CMC deliverables including submissions supporting clinical studies through initial market applications and post-approval to ensure global commercial supply.
Senior Director US Regulatory Affairs GSKSenior Director US Regulatory AffairsWarren, New JerseyAs a senior member of the Regulatory Leadership Team, this position sets regulatory direction at the category level, ensures alignment with enterprise objectives, and influences internal and external stakeholders to shape regulatory strategy, policy, and outcomes. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment.
Senior Manager, Regulatory Affairs - OTC Haleon PlcSenior Manager, Regulatory Affairs - OTCNJ$152,620–$209,852 / yearThis role requires building strong relationships with internal and external stakeholders; strategic regulatory decision-making and execution of more complex projects; leadership of cross funtional team and Health Authority interactions, and developing regulatory talent (with or without formal line management responsibilities). Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment.
Director, Regulatory Affairs Strategy Judge GroupDirector, Regulatory Affairs StrategyWarren, NJ$190,000–$220,000 / yearThis individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes.
Director, Regulatory Affairs Advertising & Promotion Acadia Pharmaceuticals IncDirector, Regulatory Affairs Advertising & PromotionPrinceton, NJ$193,400–$241,800 / yearThe position partners closely with cross-functional teams to support the timely approval and distribution of promotional and disease state materials, serves as the primary liaison with the FDA''s Office of Prescription Drug Promotion (OPDP) for advertising and promotional submissions, and contributes to labeling strategies for regulatory submissions across Acadia''s product portfolio. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
NewSenior Manager, Global Regulatory Affairs Otsuka America PharmaceuticalSenior Manager, Global Regulatory AffairsTrenton, NJProvides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead. Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL).
Regulatory Affairs Intern Phibro Animal Health CorpRegulatory Affairs InternTeaneck, NJPhibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.