- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for reviewing the ... CMC post approval changes, providing regulatory impact assessments, and coordinating with regional RA...US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC ( RA CMC) leadership and strategy to achieve regulatory ... regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory … more
- Coty (Morris Plains, NJ)
- …the global ingredient policy development and defense. This position reports to the Director , NA Regulatory Affairs and R&D Material Management and is ... Senior Manager, US Regulatory Affairs and Ingredient Support **SENIOR...regarding OTC labeling and claims. Including working with the global artwork team to maintain the Coty Artwork guidelines.… more
- Organon & Co. (Jersey City, NJ)
- … strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Merck & Co. (Rahway, NJ)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... Job DescriptionOur Clinical Research team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we… more
- Insmed Incorporated (NJ)
- …QC content for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC ... or practices from external labs.Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs , Supply Chain, and other departments to ensure… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Organon & Co. (Jersey City, NJ)
- …**The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and products, ... or regions of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide… more
- Organon & Co. (Jersey City, NJ)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location:** Morristown, NJ Cambridge, MA **About the Job** Are you ... families. Your skills could be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs - Global Labeling Strategy… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand… more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory ... for products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy… more
- Bristol Myers Squibb (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... Summary:** The selected candidate will have leadership responsibility for global regulatory strategy within a development team...PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry.… more
- Sumitomo Pharma (Trenton, NJ)
- …Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Sumitomo Pharma (Trenton, NJ)
- … Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Regulatory Affairs ( RA ) Business Operations believe talented ... be purposeful and impactful! Reporting into the Head of RA Business Operations, RA Performance Excellence, you...cycle, including roles, systems, and processes. + Familiarity with global regulatory frameworks and submission processes (eg,… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... post-approval work. Form 2252 for Annual Reports. + Provide support/ RA strategy needed to achieve timely approvals with the...industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be… more
- Bristol Myers Squibb (Princeton, NJ)
- …Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers ... Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic… more
- Chemours (Trenton, NJ)
- …living depend on Chemours chemistry. Chemours is seeking a ** Director of Regulatory Advocacy** to join our growing Government Affairs team! This position ... DC office** . The successful candidate will join Chemours' Global Government Affairs Group with a primary...Group with a primary responsibility for supporting US federal regulatory affairs engagement with the United States… more
