Associate, Regulatory Affairs- Labeling Sun Pharmaceutical Industries LtdAssociate, Regulatory Affairs- LabelingPrinceton, NJ$94,500–$105,000 / yearInitiate and provide approval for Artwork Approval Sheets for commercialization of artworks through Artwork Management System (AMS) for commercial products. 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.
Manager, Regulatory Affairs Globus Medical Inc.Manager, Regulatory AffairsAudubon, PAEssential Functions: Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval for marketing. Creates optimized regulatory strategies for 510(k) submissions, protocol development and study design, IDE / PMA submissions, and reports, to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement.
Director, Regulatory Affairs CMC Acadia Pharmaceuticals IncDirector, Regulatory Affairs CMCPrinceton, NJ$189,700–$237,100 / 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. In this leadership position, you will develop and execute global regulatory CMC strategies that support clinical development, marketing approvals, and lifecycle management across key regions including GCC, LATAM, and APAC.
Principal, Regulatory Affairs Intelligence West Pharmaceutical ServicesPrincipal, Regulatory Affairs IntelligenceExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. This role requires deep expertise in global regulatory frameworks, with a specialized focus on containment systems (i.e., primary packaging), pharmaceutical manufacturing and handling, and regulatory requirements applicable to drugs and drug constituents of combination products.
Principal Specialist, Regulatory Affairs West Pharmaceutical ServicesPrincipal Specialist, Regulatory AffairsExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. In addition, the Principal Specialist mentors team members, and provides support for global regulatory approvals (beyond US and EU), commercialized products, and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements.
R&D Manager Regulatory Affairs Wella International Operations SwitzerlandR&D Manager Regulatory AffairsHE, DESupport the development, implementation, and optimization of new system tools, digital solutions, and AI-enabled capabilities aimed at improving PS&RA efficiency, speed and productivity across Regulatory Affairs and Product Safety disciplines. Initially the position will be primarily focused on the full integration of Briogeo brand line within Wella processes and systems, thus enabling Briogeo's global innovation strategy, also behind an improvement of Briogeo's technical readiness efficiency and speed.
Principal Regulatory Affairs Project Manager, Medical Devices West Pharmaceutical ServicesPrincipal Regulatory Affairs Project Manager, Medical DevicesExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
Product Stewardship and Regulatory Affairs Sp AGC IncProduct Stewardship and Regulatory Affairs SpExton, PAEssential Functions: Supports new product registrations for Americas region, e.g., TSCA PMN/LVE/Polymer Exemptions, and Canadian DSL/NDSL notifications in close collaboration with R&D and global product stewardship teams. The position is part of a global highly interactive, diverse, and supportive team and will manage product stewardship activities to enable sales of new products and maintain the right to operate with existing products.
Director of Regulatory Affairs Avalo TherapeuticsDirector of Regulatory AffairsPhiladelphia, PAThe Director will serve as a key member of cross-functional development teams, providing regulatory leadership across clinical development, regulatory submissions, health authority interactions, and lifecycle management activities. Avalo is advancing its lead anti-IL-1 monoclonal antibody (mAb) drug candidate, abdakibart, into a phase 3 registrational program in hidradenitis suppurativa (HS), a chronic inflammatory skin condition that affects an estimated 1–4% of the population globally.
Sr Regulatory Affairs Specialist Globus MedicalSr Regulatory Affairs SpecialistAudubon, PennsylvaniaPrepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances. Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements.
Specialist 3 - Regulatory Affairs Karwell TechnologiesSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division Orthopedic devices.
Senior Regulatory Affairs Specialist West Pharmaceutical Services IncSenior Regulatory Affairs SpecialistExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. This role supports material change controls, internal and external customer regulatory requests, R&D product development, and maintaining knowledge of current US and international regulations/guidelines/policies applicable to West's products and services.
Senior Manager, Regulatory Affairs West Pharmaceutical ServicesSenior Manager, Regulatory AffairsExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. This role serves as a key bridge between regulatory experts, quality, commercial teams, and external clients to enable consistent, high‑quality execution of contracted regulatory deliverables.
Specialist 3 - Regulatory Affairs Katalyst Healthcares & Life SciencesSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division Orthopedic devices.
Scientist I - Regulatory Affairs The Campbell's CoScientist I - Regulatory AffairsCamden, NJ$68,700–$94,500 / yearOur portfolio includes the iconic Campbell's brand, as well as Cape Cod, Chunky, Goldfish, Kettle Brand, Lance, Late July, Pacific Foods, Pepperidge Farm, Prego, Pace, Rao's Homemade, Snack Factory, Snyder's of Hanover. Under general supervision, Regulatory Affairs Scientist I will support food product compliance by helping to ensure ingredients, formulas/recipes, labels, claims, and supporting documentation meet applicable food regulations, internal policies and customer requirements.
Medical and Regulatory Affairs - Medical Scientist TechDigital CorporationMedical and Regulatory Affairs - Medical ScientistTrenton, NJUnder the direct mentorship of the GI Tumor Leads, develop understanding of the assigned tumors and medical strategies, provide strategic input to a broad range of stakeholders, and facilitate strategic alignment. The primary responsibility of Medical Scientist is to support GI medical and tumor leads in translating medical strategies into tactical plans and leading the execution of these plans for assigned tumor(s).
Assoc. Dir, Regulatory Affairs-CMC Merck & Co IncAssoc. Dir, Regulatory Affairs-CMCNorth Wales, PA$142,400–$224,100 / yearRequired Skills: Change Management, Collaboration, Electronic Common Technical Document (eCTD), Emerging Technologies, Interpersonal Relationships, Liaison Work, Manufacturing Processes, Multitasking, Project Leadership, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Partnerships. Mentorship & Community Building: Propose, lead, and mentor digital project teams-including guiding GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement-while fostering collaboration across the broader AI/Digital Enablement community.
Mgr, Advocacy, Product Stewardship & Regulatory Affairs AGC IncMgr, Advocacy, Product Stewardship & Regulatory AffairsExton, PAThis role supports-and increasingly leads-product stewardship, regulatory compliance, and market access activities across the Americas, while advancing the company's policy priorities, shaping regulatory frameworks, and ensuring a supportive legislative and regulatory environment for our products. This position will advocate for our product portfolio at the U.S. federal and state levels, develop and execute North America advocacy strategies, and coordinate closely with global teams to ensure alignment on regulatory and policy priorities.
NewQuality Analyst CYNET SYSTEMSQuality AnalystTITUSVILLE, NJ$34–$39 / hourTemporaryContractorPart timeAs a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.
Associate Director Medical Affairs, Endocrine Medical Sciences - Job ID: 1965B Ascendis PharmaAssociate Director Medical Affairs, Endocrine Medical Sciences - Job ID: 1965BPrinceton, NJ$190,000–$205,000 / yearWork with internal stakeholders including Commercial, Legal, Regulatory, Clinical Development, Clinical Operations, Compliance, Pharmacovigilance, Biometrics, Global Communications, and other functional group contributors to support the US Medical Director in successful management of Medical Affairs projects, and provide medical perspective and scientific guidance within cross-functional discussions to support informed decision-making. Build and manage relationships and strategic partnerships, and interact regularly with Key Opinion Leaders/Influencers, clinical investigators, healthcare customers, strategic alliance partners, vendors, professional societies and organizations, and patient advocacy groups, and synthesize external insights to inform internal cross-functional discussions and decision-making.