- Sanofi Group (Morristown, NJ)
- …development and marketed product objectives. + Represent GRA CMC on GRAT ( Global Regulatory Affairs Team) + Assures effective involvement with change ... The team responsibilities include but are not limited to: global regulatory CMC strategies, submission...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Merck (Rahway, NJ)
- …a chance to see if we are the right company for your long-term goals Global Regulatory Affairs (GRA) Product Managers (PMs) are responsible for developing ... CMC regulatory submission strategies and timelines for...organize LoQs + Analyze and trend; develop metrics + Regulatory Affairs Detailed Application Verification (DAV)- verification,… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... and Development. Sanofi's global regulatory affairs (GRA) function is comprised of more than 1800...perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable… more
- Sanofi Group (Morristown, NJ)
- …within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within Global ... key regulatory activities and report to the Global Regulatory Device Head for Digital Health...will work closely with key stakeholders including clinical, medical affairs , Industrial Affairs (Device Development, manufacturing, quality,… more
- Merck (Rahway, NJ)
- …No **Hazardous Material(s):** n/a **Required Skills:** Cross-Functional Teamwork, Global Regulatory Submissions, Management Process, People Leadership, ... Regulatory Data + Direct and Indirect(eg, partnering with CMC , Labeling, etc) execution activities that support Data-based Submissions...Product Lifecycle, Regulatory Affairs Compliance, Regulatory … more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …+ Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and ... including preparing briefing books, planning rehearsals, and risk mitigation. Represent Global Regulatory on cross-functional teams to address regulatory… more
- Bayer (Whippany, NJ)
- …Technical Files, etc.); + Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project Teams; effectively ... diverse minds to make a real difference, there's only one choice.** **Director, Global Regulatory Strategist, CGT Combination Products** The Director, Global … more
- Sanofi Group (Morristown, NJ)
- …with all key stakeholder in GPT and Global Brand Team (GBT) + Defines global project plans and regulatory strategy together with the GPT members; leads the ... R&D components of the brand optimization strategy in close collaboration with Market Access, Global Commercial and Medical Affairs , as Active member of GPT. +… more
- Bristol Myers Squibb (Madison, NJ)
- …Management, site and above site QA and QC, Internal and External Manufacturing, Regulatory Affairs and Brand teams. The individual provides end-to-end global ... resources to serve as single points of contact for product-related changes, and Regulatory CMC liaisons responsible for coordinating reviews of regulatory … more
- Teva Pharmaceuticals (Parsippany, NJ)
- …departments such as Regulatory Affairs , Toxicology, CMC /Formulations, Biostatistics, Legal, Marketing, Accounting/Finance, Global Clinical Operations, ... working closely with other functional areas such as commercial, regulatory , pharmacovigilance, CMC , early clinical and pre-clinical...the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. **How you'll spend your… more
- Organon & Co. (Jersey City, NJ)
- …colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control ( CMC ), project management and ... are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans....live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more