Regulatory Affairs Senior Associate electroCore IncRegulatory Affairs Senior AssociateRockaway, NJThe position provides regulatory strategy input, prepares and maintains submission and technical documentation content, evaluates product and labeling changes, supports post-market and vigilance obligations, and partners cross-functionally to ensure compliant, timely execution of business objectives. • Provide practical regulatory strategy input for new products, product modifications, labeling changes, software/app updates, manufacturing changes, supplier changes, and market expansion activities.
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.
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.
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.
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).
NewAssociate 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/.
NewDirector, 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.
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).
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.
NewRegulatory Affairs Associate I The Fountain Group LLCRegulatory Affairs Associate IClark, NJBy applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Support regulatory inquiries related to hazard communication, transportation classification, waste management, and chemical inventories.
Regulatory Affairs Associate I IntelliPro Group Inc.Regulatory Affairs Associate IClark, NJThis 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 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 Associate SGS SARegulatory Affairs AssociateNJ$62,000–$75,000 / yearWith over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services. For C&H: Knowledge / experience in cosmetics, personal care or household care related testing services (microbiological, chemical, etc.) desirable (Preferred).
Senior Associate, Regulatory Affairs (US) BeOne Medicines AGSenior Associate, Regulatory Affairs (US)NY$40.91–$52.91 / hourAssist regulatory affairs team/strategist in supporting strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
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.
Regulatory Affairs Manager Hybrid Spectrum VascularRegulatory Affairs Manager HybridBridgewater, NJRole Description: The Regulatory Affairs Manager is a seasoned professional responsible for contributing to and implementing regulatory strategies and tactics for the Company with a focus on achieving product registrations as well as assuring compliance to product claims for all current and new product submissions in the US and globally. Work independently or with minimal supervision to review complex Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations.
Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy Insmed IncSenior Director, Regulatory Affairs, Global Regulatory Lead - Development StrategyBridgewater, NJRemote$222,000–$303,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. You will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA.
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 Associate, US Regulatory Affairs BeOne Medicines AGSenior Associate, US Regulatory AffairsNY$93,600–$123,600 / yearThe Sr Associate will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive. Essential Functions of the job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
NewDirector, 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.
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.
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.
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.
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.
Associate Director Regulatory Affairs Advertising & Promotion Hybrid AbbVie IncAssociate Director Regulatory Affairs Advertising & Promotion HybridFlorham Park, NJThe Associate Director envisions the future by using global marketplace, technology and business knowledge, collects and analyzes issues and trends that affect the business, identifies and acts upon cross-organization or cross-business opportunities and possesses and leverages broad industry knowledge. Applicable 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.
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.
Associate Director, Regulatory Affairs, CMC BeOne Medicines AGAssociate Director, Regulatory Affairs, CMCNY$142,000–$192,000 / yearManage, prepare, and/or author CMC document packages for global regulatory submissions in support of development and lifecycle programs, including primary authorship and/or leadership of Module 3 (Quality) sections for INDs, CTAs, IMPDs, BLAs, MAAs, supplements, and variations. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity.
Associate Director, Regulatory Affairs Recursion Pharmaceuticals IncAssociate Director, Regulatory AffairsNYRemote$176,400–$207,500 / yearCreate and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter faster, better, and at scale for patients who are waiting.
Senior Associate, Regulatory Affairs, Promotional Operations BeOne Medicines AGSenior Associate, Regulatory Affairs, Promotional OperationsNY$93,600–$123,600 / yearActual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Essential Functions of the Job: Assists in acting as a centralized knowledge hub of Promotional Review Committee (PRC) and provides guidance to project owners/agencies/reviewers on the process to streamline material review.
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.
NewDirector, Global Regulatory Affairs & Clinical Safety Business Development Merck & Co IncDirector, Global Regulatory Affairs & Clinical Safety Business DevelopmentRahway, NJ$173,200–$272,600 / yearWork with the staff to manage the strategy, negotiation, and provisions of regulatory components of agreements as they relate to product acquisitions, collaborations, distribution, comarketing, copromotion, tech transfer, joint ventures, and divestitures. More specifically, this position will oversee staff who will manage the business development stages of strategy, evaluation, due diligence, contracting, implementation support and maintenance of regulatory activities relating to our Company business partner deals.
Associate Director, Regulatory Affairs BeOne Medicines AGAssociate Director, Regulatory AffairsNY$146,700–$196,700 / yearProvides strategic and operational regulatory direction on assigned projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, risk assessments, critical issue management and advice on health authority interactions. Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
Legal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VP Bank of ChinaLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VPNew York, New York$110,000–$230,000 / yearFull timeOversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. The VP establishes and maintains RAO policies/procedures and oversees all Regulatory Affairs Matters, including project management, stakeholder relationships, and day-to-day processes, communication with regulators, tracking and coordinating regulatory deliverables, driving the submission process to ensure timely execution and quality assurance, and reporting regulatory updates to Bank Management and committees.
Legal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VP Bank of China Limited, New York BranchLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VPNew York, New York$110,000–$230,000 / yearFull timeOversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. The VP establishes and maintains RAO policies/procedures and oversees all Regulatory Affairs Matters, including project management, stakeholder relationships, and day-to-day processes, communication with regulators, tracking and coordinating regulatory deliverables, driving the submission process to ensure timely execution and quality assurance, and reporting regulatory updates to Bank Management and committees.
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.
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.
Executive Director, Regulatory Affairs - Global Regulatory Leader Summit Therapeutics IncExecutive Director, Regulatory Affairs - Global Regulatory LeaderNY$231,000–$285,000 / yearOverview of Role: The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.
Associate Director, CMC Regulatory Affairs Recursion Pharmaceuticals IncAssociate Director, CMC Regulatory AffairsNYRemote$176,400–$228,250 / yearPowered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter - faster, better, and at scale - for patients who are waiting. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need.
Analyst, Regulatory Affairs Oscar Health IncAnalyst, Regulatory AffairsNY$31.45–$41.28 / hourYou will support the Regulatory Affairs Evidence of Coverage team by serving as a resource on Oscar processes and identify risks to escalate in partnership with their manager. Responsibilities: Support annual QHP filings by ensuring the quality and timeliness of annual filing inputs through initial submission and regulator facing negotiation periods.
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion Syndax Pharmaceuticals IncDirector, Commercial Regulatory Affairs, Labeling, Advertising, and PromotionNYRemote$225,000–$250,000 / yearConducts precedent searches, analyzes relevant analogs or competitor labeling, labeling guidance and trends; and develops labeling language for inclusion to assigned product labels (TLP, CCDS, USPI, when applicable EU SmPC,) to ensure consistency with the overall product strategy, product claims and information in the CCDS. Leads Labeling cross-functional working group (LWG) and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives by providing expertise in labeling best practices.
Senior Director, Regulatory Affairs - Development Strategy Insmed IncSenior Director, Regulatory Affairs - Development StrategyNJRemote$222,000–$303,000 / yearFor New York City Residents: To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool ("AEDT") that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. This role will provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions, and act as the primary regulatory contact for the US FDA.
NewRegulatory 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.
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.
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 Manager Regulatory Affairs US Advertising and Promotion - US Specialty AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - US SpecialtyFlorham Park, NJOversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act. Applicable 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.
Medical Device Regulatory Affairs Strategist Oracle CorpMedical Device Regulatory Affairs StrategistNYRemote$87,000–$178,100 / yearAs a Principal/Lead/Senior Regulatory Affairs Specialist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). About the Role: At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry.
Staff Specialist, Regulatory Affairs Stryker CorpStaff Specialist, Regulatory AffairsMahwah, NJRemote$77,700–$129,500 / yearHowever, 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. This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.
Director, US Advertising and Promotion, Global Regulatory Affairs SanofiDirector, US Advertising and Promotion, Global Regulatory AffairsMorristown, NJ$178,500–$257,833.33 / yearEstablishes and develops key internal relationships with therapeutic product leaders in Commercial organization, R&D and Corporate functions (e.g., Communications, Compliance, Legal) to foster open communication and teamwork. The Director is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports (if applicable) in order to meet internal and external customer needs.
NewSenior 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.