- 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)
- …responsibilities.Proven track record in setting and delivering product strategy in regulatory affairs and pharmacovigilance domains, with an ability to ... or equivalent regulatory authoring/publishing platforms.Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing,… 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
- 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
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Regulatory Affairs Diagnostics. This ... application. We invite candidates from any location to apply. The Associate Director , Global Regulatory Affairs Diagnostics will provide an opportunity… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a ... preferred. + 8-12 years pharmaceutical industry experience, including 6-8 years in regulatory affairs . Global experience strongly preferred with command… 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
- 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
- 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
- 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
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... target labeling for new products. + Take a leadership role and partner with Global Regulatory Leads (GRLs) and other functional area partners (clinical, safety,… more
- Merck (Rahway, NJ)
- …+ Proven track record in setting and delivering product strategy in regulatory affairs and pharmacovigilance domains, with an ability to execute ... regulatory authoring/publishing platforms. + Demonstrated experience delivering regulatory affairs and pharmacovigilance technology solutions (authoring/publishing,… more
- Sanofi Group (Morristown, NJ)
- …, etc.) + Partners effectively with relevant departments (eg Commercial, Clinical Development, Regulatory Affairs , Medical Affairs , HEOR, etc.) to influence ... **Job Title:** Director , Global Market Access and Pricing...access and pricing strategy in partnership with the therapeutic global cross-functional colleagues (eg Commercial, Clinical, medical, regulatory… more
- J&J Family of Companies (Raritan, NJ)
- …matrix interactions also includes individuals from project management, operations, regulatory affairs , data management, medical writing, biostatistics, ... adverse events (pre and post-marketing) for relationship to treatment + Assists Regulatory Affairs in determining requirement for any corrective actions or… 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
- Bristol Myers Squibb (Madison, NJ)
- …Science and Technology, Business Process Management, Internal and External Manufacturing, Regulatory Affairs , Brand Teams, Legal, Patient Safety, Medical ... executed in strict adherence to applicable regulations and BMS standards. The Executive Director leads a team dedicated to maintaining global compliance across… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …Pharmacy, or related fields, required. + 10+ years of relevant experience in regulatory affairs , compliance, or quality assurance in the pharmaceutical, biotech, ... inspections in pharmaceutical (medical device, biologics) facilities. + In-depth knowledge of global regulatory requirements (FDA, EMA, PMDA, etc.) and GxP… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …Relationship/Scope: + This position reports to the Head of Global Medical Affairs . The Senior Medical Director will interact with internal colleagues in the ... Medical Department, Marketing, Sales, Research and Development, strategy/portfolio management, Regulatory Affairs , and Pharmacovigilance. External collaboration includes… more
