Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
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).
Regulatory Affairs Specialist Terumo Medical CorpRegulatory Affairs SpecialistSomerset, NJ$61,440–$84,480 / yearTerumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.
Staff Specialist, Regulatory Affairs StrykerStaff Specialist, Regulatory AffairsMahwah, New JerseyRemoteHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Work Flexibility: Remote or Hybrid or Onsite Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for our Joint Replacement implant and instrument portfolio across U.S and international markets .
Regulatory Affairs Specialist Actalent IncRegulatory Affairs SpecialistMahwah, NJ$28–$33 / hourCoordinate, prepare, and review regulatory documents and certifications for example: Specifications, Safety Data Sheets (SDS), Flavor/Fragrance Allergens, BE/GMO, Organic, Natural, IFRA, Country of Origin, GRAS, Kosher, Nutritional. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
NewSenior Regulatory Affairs Specialist - Dairy Flora Food GroupSenior Regulatory Affairs Specialist - DairyHackensack, New JerseyWorking 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.
NewRegulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaNJ$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Senior Specialist, Regulatory Affairs ImmunityBio IncSenior Specialist, Regulatory AffairsSummit, NJImmunityBio, 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. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Regulatory Affairs Specialist Hybrid Spectrum VascularRegulatory Affairs Specialist HybridBridgewater, NJThis role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Innovation has been a core strategic pillar throughout our history and many of our products have been designed to deliver antimicrobial and antithrombogenic protection or to support certain patient populations such as those who are critically ill and pediatrics.
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 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 Associate I IntelliPro GroupRegulatory Affairs Associate INew JerseyThis role will focus on reviewing product formulas and artwork for regulatory compliance, supporting product notification and registration processes, and maintaining documentation related to regulatory requirements. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more.
Regulatory Affairs Associate II LanceSoft IncRegulatory Affairs Associate IIPrinceton, NJ$50–$55 / hourMajor Accountabilities: To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional artwork review and preparation, and to contribute to the achievement of functional objectives. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
Regulatory Affairs Associate Aurobindo Pharma LtdRegulatory Affairs AssociateEast Windsor, NJDeprecated: preg_replace_callback(): Passing null to parameter #3 ($subject) of type array|string is deprecated in C:\api\public\classes\StringCleaner.class.php on line 100.
Program Development Analyst (Regulatory Affairs Associate) Actalent IncProgram Development Analyst (Regulatory Affairs Associate)New Brunswick, NJRemote$35–$40 / hourThis position involves working closely with various stakeholders, including investigators, network staff, industry sponsors, and regulatory bodies, to streamline protocol approvals and maintain comprehensive regulatory documentation. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Regulatory Affairs Associate II Apidel TechnologiesRegulatory Affairs Associate IIPrinceton, NJContractorMajor Accountabilities: To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional artwork review and preparation, and to contribute to the achievement of functional objectives. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
Regulatory Affairs Associate I Buckeye GlobalRegulatory Affairs Associate IClark, NJResponsibilities include completing hazard assessments of final and intermediate formulations, preparing hazard communication documentation, maintaining product information databases and confirming compliance with health and safety, transportation and waste requirements. **Applicable Shift: Onsite 100% during about 2 months training period; after that, potential for hybrid (3 days onsite, 2 days remote) - training period is subject to change, hybrid is subject to review.
Associate Director, Regulatory Affairs Advertising & Promotions Tris Pharma IncAssociate Director, Regulatory Affairs Advertising & PromotionsMonmouth Junction, NJ$180,000–$225,000 / yearTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. Bachelors degree in life sciences, pharmacy, medicine or a related discipline and minimum of 7 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED.
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.
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 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.
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/ .
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.
Assoc Director, Regulatory Affairs - Advertising and Promotion Merck & Co IncAssoc Director, Regulatory Affairs - Advertising and PromotionRahway, NJ$129,000–$203,100 / yearRequired Skills: Clinical Trials, Cross-Functional Teamwork, Data Analysis, Detail-Oriented, Electronic Common Technical Document (eCTD), FDA Regulations, Negotiation, Pharmaceutical Industry, Promotional Review, Regulatory Compliance, Regulatory Labeling, Regulatory Strategies, Regulatory Submissions, Stakeholder Management, Strategic Thinking, US Regulatory Affairs. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of study results in U.S. promotion.
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/
Associate Director, Regulatory Affairs - Biosimilars (US) Sandoz Group AGAssociate Director, Regulatory Affairs - Biosimilars (US)Princeton, NJ$145,600–$279,400 / yearWith investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
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.
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.
NewAssociate Director, Regulatory Affairs Project Management Insmed IncAssociate Director, Regulatory Affairs Project ManagementNJRemoteReporting to the Director, Regulatory Affairs Project management, you'll work with global submission teams to project, manage complex regulatory submissions (including global marketing applications, product line extensions, and supplements) from submission preparation to approval, ensuring that applications and dossiers are prepared in a timely manner and in compliance with Regulatory Authority regulations and guidance's and Insmed Operating procedures. Have and be able to utilize in-depth knowledge of global regulatory submission requirements, processes and procedures, eCTD structure/format, associated Insmed systems and planning software to ensure teams meet aggressive target submission dates by proactively focusing on critical path analysis, hand offs, scenarios, and reducing "rework" to avoid costly time delays.
NewAssociate Director, Regulatory Affairs Intelligence Novartis AGAssociate Director, Regulatory Affairs IntelligenceEast Hanover, NJ$67,900–$126,100 / yearExpected Annual Base Salary Range for role: £67,900 to £126,100 The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. This is an exciting opportunity to combine regulatory expertise, strategic thinking, digital innovation, and stakeholder leadership to deliver meaningful impact across Novartis and ultimately improve patient outcomes worldwide.
Associate Director, Global Regulatory Affairs, Advertising & Promotion GenmabAssociate Director, Global Regulatory Affairs, Advertising & PromotionPrinceton, NJFull timeFor 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. Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
Associate Director, Regulatory Affairs Advertising and Promotion Recordati SpAAssociate Director, Regulatory Affairs Advertising and PromotionBridgewater, NJ$137,600–$180,000 / yearRecordati Rare Diseases, Inc. (RRD) develops high-impact therapies for rare diseases, focusing on providing treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, better diagnoses, and improved treatment access in endocrinology, metabolic, hematology and oncology franchises. This role is responsible for supporting regulatory review and activities related to advertising / promotion of our marketed pharmaceutical products in 1 or 2 of the following therapeutic areas: oncology, endocrinology, hematology.
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 Eikon Therapeutics IncDirector, Regulatory AffairsJersey City, NJ$213,000–$232,750 / yearThis role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
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.
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.
Attorney Government and Regulatory Affairs Malamut & AssociatesAttorney Government and Regulatory AffairsCherry Hill, New JerseyWith extensive experience, we deliver positive results for our clients, specializing in representing state, county, and local governments in a variety of matters, as well as clients in Personal Injury and Employment Law. Since our founding, the Firm has built a reputation for competent and ethical representation of our clients in matters of Personal Injury, Workers Compensation, Employment & Labor, and Government & Regulatory Affairs.
Director, Regulatory Affairs - CMC Rocket Pharmaceuticals IncDirector, Regulatory Affairs - CMCCranbury, NJ$204,000–$244,000 / yearThey will formulate and implement global CMC regulatory strategies for the development of gene therapy programs that are in line with global requirements and coordinate all aspects of CMC regulatory submissions relevant to assigned projects or programs. Rocket Pharma is seeking a Director, Regulatory Affairs - CMC (Chemistry, Manufacturing, and Controls to support the success of our gene therapy programs by serving as the global product leader for CMC regulatory strategy.
Executive Director, Medical Affairs Celldex Therapeutics IncExecutive Director, Medical AffairsNJ$233,631–$303,417 / yearAdvanced scientific degree required (MD, PhD, PharmD or equivalent) 10-15+ years of combined clinical and/or biopharma experience, including Medical Affairs leadership in Immunology, Allergy, and/or Dermatology; launch experience strongly preferred Prior people management (direct reports) and matrix leadership across Field Medical (MSLs) and in‑house medical teams Proven track record leading publications/scientific communications programs and compliant data dissemination Exceptional scientific acumen and communication; ability to translate complex data for clinical, regulatory, commercial, and access stakeholders Strength in publication strategy/execution, KOL development, advisory board design, and congress/symposia strategy and execution Omni‑channel mindset with facility applying insights/analytics to optimize medical impact High integrity and strong judgment in a multi‑functional matrix; skilled in prioritization, budgeting, and vendor management Willingness to travel ~25-30% for priority engagements and congresses. Therapeutic area medical affairs strategy and planning Develop Medical Affairs strategies and plans focused on scientific communications and engagements with medical community to build Celldex presence and capabilities in Allergy and Dermatology Lead a team of Medical Affairs specialists to develop a strategically and commercially aligned scientific engagement and communication strategy for key immunology assets in Allergy and Dermatology therapeutic areas Provide disease‑area subject matter expertise on behalf of Medical Affairs to cross-functional partners, including Commercial (Marketing, Value and Access), R&D (clinical development, translational medicine, medical safety) to inform study designs, labels, and postmarketing commitments.
Scientific Medical Director Global Hematology Pipeline Medical Affairs AbbVie IncScientific Medical Director Global Hematology Pipeline Medical AffairsFlorham Park, NJThe Scientific/Medical Director, Global Hematology Pipeline, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities across the hematology pipeline including disease and asset strategy, scientific differentiation, value propositions, narratives and publication strategy, evidence generation and health-care professional and provider interactions. Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate.
Regulatory Specialist Air LiquideRegulatory SpecialistFairfield, New Jersey$100,000–$130,000 / yearR10094604 Regulatory Specialist (Open) Location: Fairfield, NJ (Seppic) - Sales - North America zone An Air Liquide Healthcare company, subsidiary of the Air Liquide group, Seppic has been designing, manufacturing, and marketing unique ingredients for over 75 years. Operating at the intersection of regulatory affairs and client relations, this role is critical to managing global documentation requests, ensuring adherence to FDA guidelines, and collaborating closely with internal stakeholders and external manufacturing principals.
NewDirector - North America Medical Affairs Hikma Pharmaceuticals PlcDirector - North America Medical AffairsBerkeley Heights, NJ$121,000–$220,000 / yearThe role serves as the strategic bridge between Hikma's R&D, Regulatory Affairs, Pharmacovigilance (PV), Quality, Commercial, Legal, and Compliance on the one hand and the external community of healthcare professionals, pharmacies, payers and insurers, medical boards and professional societies, health-system and policy decision makers, and patient advocacy groups on the other. The role oversees a focused but rapidly expanding footprint, including current in-house medical science liaison (MSL) coverage supporting an established hospital injectable product and upcoming launch programs requiring an MSL field team of approximately 1-5 professionals.
Regulatory Transformation Specialist - Field Action Integra LifeSciences Holdings CorpRegulatory Transformation Specialist - Field ActionPrinceton, NJ$71,300–$97,750 / yearSupport the execution and tracking of global regulatory field action activities, including monitoring regulatory requirements, maintaining country-specific timelines, and ensuring required documentation (e.g., notifications, effectiveness checks, closure records) is complete, accurate, and inspection-ready. Support enterprise regulatory transformation team initiatives with a primary focus on Field Actions, including recalls, corrections and removals, FSN/FSCA activities, and other postmarket regulatory obligations, while supporting additional transformation priorities as needed.
NewSenior Global Medical Affairs Leader - H&N Cancer 6085-Janssen Global Services Legal EntitySenior Global Medical Affairs Leader - H&N CancerRaritan, New JerseyAnalytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Process Optimization, Product Strategies, Stakeholder Analysis, Strategic Thinking . The sGMAL will partner closely with the GMA Operations Leader, Marketing and Market access leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans.
Executive Director - Global Scientific Marketing Affairs, Companion Animal Merck & Co IncExecutive Director - Global Scientific Marketing Affairs, Companion AnimalRahway, NJ$231,900–$365,000 / yearRequired Skills: Budget Management, Business Compliance, Business Expansion, Conflict Resolution, Cross-Cultural Awareness, Customer-Focused, Financial Budgeting, Interpersonal Relationships, Key Opinion Leader Management, Marketing Communications (MarCom), Market Research, Medical Affairs, Pricing Strategies, Product Management, Professional Networking, Public Finance Management, Segmentation Strategy, Strategic Decisions, Transformational Leadership, Veterinary Medicine. The Executive Director - Global Scientific Marketing Affairs, Companion Animal, reports directly to the Associate Vice President of the Companion Animal Business Unit and will lead a core team of technical services directors with a scope of influence extending globally, and who influence extended teams consisting of 10 to 100 commercial and technical services team members across all geographies.
NewSenior Global Medical Affairs Leader - H&N Cancer J&J Family of CompaniesSenior Global Medical Affairs Leader - H&N CancerRaritan, NJ$196,000–$342,700 / yearAnalytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Process Optimization, Product Strategies, Stakeholder Analysis, Strategic Thinking. The sGMAL will partner closely with the GMA Operations Leader, Marketing and Market access leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans.
NewAssociate Director, US Government Affairs GenScript ProBioAssociate Director, US Government AffairsPiscataway, New JerseyLeverage learnings with key elected officials to update message points to ensure GenScript and ProBio can (1) describe succinctly what we do, (2) the impact we have in the biotech ecosystem, (3) respond to any concerns raised, or anticipated to be raised, by elected officials, and (4) prepare what we need from each elected official in anticipation of being asked this question from an elected official. Founded in 2002 in New Jersey, GenScript Biotech Corporation accelerates innovation in biotech and healthcare by providing researchers and companies with the building blocks needed to develop groundbreaking treatments and products.
NewSenior Global Medical Affairs Leader - H&N Cancer Johnson & JohnsonSenior Global Medical Affairs Leader - H&N CancerRaritan, NJ$196,000–$342,700 / yearRequired Skills: Preferred Skills: Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Process Optimization, Product Strategies, Stakeholder Analysis, Strategic Thinking. The sGMAL will partner closely with the GMA Operations Leader, Marketing and Market access leader, Regional Medical TA/product leaders and Clinical Development Leader to develop an integrated global medical affairs perspectives, strategies and plans.
Global Medical Affairs Leader, Prostate 6085-Janssen Global Services Legal EntityGlobal Medical Affairs Leader, ProstateRaritan, New JerseyAnalytical Reasoning, Business Requirements Analysis, Clinical Research and Regulations, Clinical Trials Operations, Communication, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Product Strategies, Stakeholder Analysis, Strategic Thinking, Workflow Analysis . The Global Medical Affairs Lead for Prostate Cancer will be responsible for leading aspects of the optimization for our strategy and launch readiness for our asset in development in prostate cancer leveraging our next-generation T cell engagers and immuno-oncology platform and its life cycle management strategies.
Director, Medical Affairs - Portfolio - East Novo Nordisk ASDirector, Medical Affairs - Portfolio - EastPlainsboro, NJ$250,000–$320,000 / yearPosition provides field coaching, mentorship and management to the field-based Medical Liaisons and develops and implements strategies aligned to identified territory archetype that: optimally manage key opinion leader/organized providers/academic institutions/integrated delivery networks and other key health care provider/organization relationships, specifically with the provision of timely and up to date scientific information relevant to customer needs and aligned to NNI patient value framework ensure personal development of the team, and ensure collaboration between the field-based Medical Liaison team and other NNI units / personnel. Reviews, evaluates, and channels information to the appropriate NNI personnel, if needed, and provides timely responses to requests from the Medical Liaisons for support of various activities from contacts in their respective region: (1) financial support of research, teaching, and CME activities, (2) product or technical services to conduct and/or publish research (3) technical services to aid in educational endeavors, (4) product and disease information, and (5) participation in consulting activities or clinical studies.