- Sanofi Group (Morristown, NJ)
- **Job Title:** Global Regulatory Affairs CMC lead **Location:** Framingham, MA/ Waltham, MA/ Morristown, NJ **About the Job** Are you ready to shape the ... we chase the miracles of science to improve people's lives. The Global Regulatory Affairs (GRA) CMC & Device Organization within Sanofi R&D serves as a… more
- Merck (Rahway, NJ)
- …Team. This Lead plays a critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global Regulatory ... This individual will be a senior member of the Regulatory Affairs CMC organization and... Regulatory Affairs Global Regulatory Policy and the Head of CMC … more
- Parexel (Trenton, NJ)
- Exciting opportunity for an experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...regulatory efficiency and readiness * Participate in monthly CMC Global Regulatory Team meetings… 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
- Parexel (Trenton, NJ)
- …development and approved programs, helping to shape the future of life-saving therapies. As a ** CMC Regulatory Affairs Senior Associate** , you will play a ... lifecycle management. **Key Responsibilities** + Develop and implement comprehensive global CMC regulatory strategies for...(advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the… more
- Actalent (Parsippany Troy Hills, NJ)
- Job Title: CMC Regulatory Affairs Scientist Job Description As a CMC Regulatory Affairs Scientist, you will play a crucial role in the design and ... with pharmaceutical development and industrial operations teams to generate CMC regulatory dossiers. + Participate in industry...on Oct 16, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent… more
- Organon & Co. (Jersey City, NJ)
- …biological/pharmaceutical research, manufacturing, analytical testing or a related field. + Regulatory CMC global post-approval lifecycle management + ... regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory...business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to… more
- Sumitomo Pharma (Trenton, NJ)
- …position of **Director Regulatory Affairs ** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …units as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution...experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical… more
- Bausch + Lomb (Trenton, NJ)
- …the advancement of eye health in the future. **Objectives:** Lead and execute global regulatory strategies for development programs and marketed products across ... activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA,...Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a… more