- Merck & Co. (Rahway, NJ)
- …Leadership Team.-This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... MAA) and limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and… 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
- 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
- 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)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside. + Communicate new ... **Job Description** **The Position** The Associate Director , Global Regulatory Lead...the entire life cycle of the drug. + Represent Global Regulatory Affairs within our… 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 (Madison, 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
- 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
- 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
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …relevant stakeholders, typically carrying out the responsibilities with guidance from the Regulatory Affairs , Advertising and Promotion Director . The Manager ... a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs , Advertising & Promotion Director . + Creatively contribute… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …stakeholders, typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs , Advertising and Promotion Director . The Senior ... typical day might include:** + Management of US and Global (if applicable) regulatory activities associated with...advertising and promotion perspective with minimal guidance from the Regulatory Affairs , Advertising & Promotion Director… 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
- System One (Florham Park, NJ)
- Job Title: AD or Director , Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be ... development, not just life cycle management. Overview Support the Regulatory Affairs (Executive Director ) in...to provide background insights. + Assist in Coordinating with Global Regulatory Counterparts to Align Regional Strategies… 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 CMC, the Associate...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Merck (Rahway, NJ)
- …Leadership Team. This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... limited CMC post-approval changes. + Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and the… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …relevant stakeholders, typically carrying out the responsibilities independently. The Associate Director Regulatory Affairs , Advertising and Promotion will ... Regeneron's Regulatory Affairs Organization is seeking an Associate Director...you if you can:** + Management of US and Global regulatory activities associated with advertising and… 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
- Sanofi Group (Morristown, NJ)
- …their families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse ... **Job Title:** GRA Device Lead (Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham,...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
