- 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 ... 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with… more
- J&J Family of Companies (Raritan, NJ)
- …of all global oncology PAA programs working with R&D, medical affairs , market access, real world evidence, regulatory , CMC , pharmacovigilance, ... every step of the way. Learn more at https://www.jnj.com/innovative-medicine The Senior Global Medical Affairs Leader (Sr. GMAL) for oncology pre-approval access… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Senior Specialist Regulatory Affairs executes on the pharmaceutical regulatory strategies for ... Join a team! We are a global diversified pharmaceutical company enriching lives through our...Authorities for assigned brand products + Liaise with country-specific regulatory affairs personnel for international submissions and… more
- Bausch Health (Bridgewater, NJ)
- …and values drive our collective progress and impact. The Associate Director, Regulatory Affairs handles regulatory development and post-approval/ ... assigned pharmaceutical products. + Coordinate/Liaise with BHC country-specific pharmaceutical Regulatory Affairs personnel for international submissions and… 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible ... fit for purpose and compliant with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality, CSPV,… 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
- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC , and Clinical Development to ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more