- 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
- 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
- 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
- Bausch + Lomb (Trenton, NJ)
- …strategies across CMC and clinical/non-clinical, labeling, adpromo domains + Lead all CMC regulatory activities for IND, NDA and ANDA submissions and OTC ... Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and...Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …+ Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory strategies for Biologics, Biosimilars, and ... balancing business benefits and risks. + Lead and Manage Global Regulatory Submission Activities: Oversee submission planning,...compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures… more
- Sanofi Group (Morristown, NJ)
- …of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global ), in early ... teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner...and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated… 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 (Princeton, NJ)
- …lives. Read more: careers.bms.com/working-with-us . **Position Title:** Vice President, Global Program Lead Neuroscience **Position Summary:** The Global ... assets. The GPL role is accountable for leading the Global Program Team and orchestrating the design and execution...with the cross functional GPT members + Participates in regulatory filings (NDA, BLA filings) as well as develops… 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 ... of products. The team is part of the GRA CMC & GRA Device Department within Global ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… 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 ... of products. The team is part of the GRA CMC & GRA Device Department within Global ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… 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 ... of products. The team is part of the GRA CMC & GRA Device Department within Global ...team creates and maintains strong collaborative working relationships with Global Regulatory Affairs (GRA), Regional… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …by closely working with MTP internal colleagues in various functions (Quality Assurance, Regulatory Affairs , Marketing, Market Access, Medical Affairs , Drug ... effectively with colleagues in Supply Chain, Accounting, Market Access, Quality Assurance, Regulatory Affairs , Finance, etc. of Mitsubishi Tanabe Pharma Group,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and Teva Standard Operating Procedures + Partners cross-functionally with departments such as Regulatory Affairs , CMC , Biostatistics, GCO, in the execution ... will be a key contributor to INDs, NDAs, BLAs, and other global regulatory filings and publications. The Director will foster relationships with opinion leaders… 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