- Sanofi Group (Morristown, NJ)
- …collaboration with R&D functions, Industrial Affairs , Global Regulatory Affairs . + Coordinate the submission of CMC regulatory files and ... (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. +...allotted. + Author the CMC strategy document " Global Regulatory CMC Strategy Document"… 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)
- … product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical ... business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to...the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC… 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
- 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)
- …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
- 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
- System One (Florham Park, NJ)
- …with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, ... documents for electronic submissions. + Coordinate with cross-functional teams, including Regulatory Affairs , Clinical Development, and Quality Assurance, to… more
- Cardinal Health (Trenton, NJ)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... approvals. More specifically, this role serves the function to support global , post-approval lifecycle regulatory requirements for Biologics and small-chemical… more
- Cytel (Trenton, NJ)
- …with cross-functional teams, including analytical scientists, process engineers, and regulatory affairs , to develop and implement appropriate statistical ... Bayesian analysis experience and had exposure to Chemistry, Manufacturing, and Controls ( CMC ) data analysis. You are excited and enthusiastic, motivate your teams to… more