- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... science or healthcare preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional experience in the… more
- Merck & Co. (Rahway, NJ)
- …and is responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development ... Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Regulatory Affairs … more
- Eisai, Inc (Nutley, NJ)
- …to the health economics and outcomes research strategies, and timelines with medical affairs , marketing, managed markets and global value and access teams. ... difference. If this is your profile, we want to hear from you. The Director , US HEOR and RWE (field) is responsible for developing HEOR engaging population-based… more
- Merck & Co. (Rahway, NJ)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Job DescriptionOur company is a global health care leader with a diversified portfolio...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… 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
- Merck & Co. (Rahway, NJ)
- …(V&I) Outcomes Research, position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research.Under ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers and Global Value Dossiers for use by local subsidiaries in their HTA submissions.The… more
- Organon & Co. (Jersey City, NJ)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate...the product lifecycle.?? + Lead development and execution of global product and project regulatory strategy(ies) by… more
- Merck & Co. (Rahway, NJ)
- …and executing integrated development plans that align clinical, medical affairs , commercial, manufacturing, regulatory , analytical, and epidemiological ... DescriptionOur Clinical Research and Pharmacovigilance team pushes the boundaries of global healthcare through research and innovation. Through clinical trials and… 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 ... Position** Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… 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 ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …aspirations. Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs , you will act as ... Affairs and may serve as Regional Regulatory Lead or Global Regulatory ...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
- AbbVie (Florham Park, NJ)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director , Regulatory Affairs Global Regulatory ... products in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ... critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs -...training and team leadership opportunities. We are an innovative global healthcare company with one purpose: to chase the… more
- Merck (Rahway, NJ)
- …and is responsible for the business process and related activities associated with Global Regulatory Affairs and Clinical Safety (GRACS) Business Development ... Mergers and Acquisitions (M&A), Negotiation, Out Licensing, People Leadership, Pharmaceutical Regulatory Affairs , Pharmacovigilance, Regulatory Affairs … more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Medical Affairs Director - Oncology **Location:** Cambridge, MA / Morristown, NJ **About the job** **About us:** In order to pursue ... engagement. We serve as key strategic partners for commercial, regulatory , R&D, market access and external affairs ...address highest unmet needs. Sanofi is recruiting a new Director in Global Medical Affairs … more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be...Use various labeling software tools such as TVT and/or Global Vision. Can be trained and have direct reports… more
