- Insmed Incorporated (NJ)
- …for each 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-CMC leaders to formulate regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a healthcare industry required- 4 or More… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Quality Control will be responsible for leading and overseeing all ... for regulatory filings (IND, NDA, BLA), and collaborate with Regulatory Affairs to prepare high-quality responses to agency queries involving QC data or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… 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 ... changes the way we approach serious diseases. --The Senior Director will report to an Associate Vice...Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance… 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 ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Organon & Co. (Jersey City, NJ)
- …**The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Organon & Co. (Jersey City, NJ)
- …development programs with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, Manufacturing ... and Controls (CMC), medical affairs and business development. Non-Clinical Safety Assessment Representative is...for reviewing and authoring non-clinical and clinical modules for regulatory submissions, briefing books and other regulatory … more
- Organon & Co. (Jersey City, NJ)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will ... trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is… more
- Sumitomo Pharma (Trenton, NJ)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , 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… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- Associate Director , Regulatory Affairs Department: Regulatory Affairs Location: Elmwood Park, NJ START YOUR APPLICATION ... in the pharmaceutical industry with at least 10+ years- experience in a regulatory affairs . + Primary experience must be managing a significant number of generic… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** As an Associate Director , Global Regulatory Affairs , you will act as the Regional ... role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. Position will be filled in either Foster City,… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Associate Director , Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are ... was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional brand and… more
- United Therapeutics (Trenton, NJ)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… 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 ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical… more
- AbbVie (Florham Park, NJ)
- …and effectively, throughout the product lifecycle and the patient's journey. The Associate Scientific Director provides medical and scientific strategic and ... discovery, statistics, regulatory , etc.) as they relate to on-going medical affairs projects. + May assist as consultant and liaison with other corporations when… more
- J&J Family of Companies (Titusville, NJ)
- …America, Titusville, New Jersey, United States of America **Job Description:** **Senior Manager/ Associate Director , Regulatory Medical Writing X-TA** At ... We are searching for the best talent for a **Senior Manager** **/ Associate Director ** , ** Regulatory Medical Writing** within our… 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 ... a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Labeling Product Leader. This position is a hybrid… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA Device Lead ( Associate Director ) **Location** : Morristown, NJ/ Cambridge, MA/ Framingham, MA **About the Job** Are you ready to shape the ... could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the medical… more
