- Insight Global (Summit, NJ)
- Job Description Insight Global is looking for a CMC Regulatory Consultant to join the Regulatory Affairs organization within R&D at a Consumer Healthcare ... organization. This individual will be responsible for authoring, reviewing, and approving regulatory documents and submissions within Module 2 and Module 3. They… more
- Sanofi Group (Morristown, NJ)
- …thought was possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects ... Affairs, Global Regulatory Affairs. + Coordinate the submission of CMC regulatory files and contribute to the preparation and review; in collaboration with… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Principal Scientist (Director) Regulatory CMC is responsible for Regulatory Chemistry Manufacturing & Controls ( ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… more
- Organon & Co. (Jersey City, NJ)
- …assigned products across the product lifecycle + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management, as ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- Organon & Co. (Jersey City, NJ)
- … strategies for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes ... business development due diligence activities. **Responsibilities** + Provide global strategic regulatory CMC overview for respective products and portfolio. +… more
- Sanofi Group (Morristown, NJ)
- …the writing and content generation for reports leading to the authoring of CMC dossier content for regulatory submissions and quality documentation. This is ... studies, life cycle management activities, and manufacturing assistance projects to compile CMC documentation for technical reports for Regulatory and Quality… more
- Deloitte (Morristown, NJ)
- …(ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA/EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years ... experience + 4+ years Life Sciences Chemistry, Manufacturing, and Controls ( CMC ) experience to include: + Introducing new technologies like GenAI, AI/ML,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- Sanofi Group (Morristown, NJ)
- …in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable. + Demonstrated experience with preparation ... **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the...accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global… more
- Bayer (Whippany, NJ)
- …+ Deep understanding of Pharmaceutical R&D business processes (preclinical, Clinical, CMC , Regulatory , PV) and underlying data, procedures, policies and ... to R&D data management with an initial specific focus on product and regulatory data. This role has broad accountabilities for the following 1. Regulatory… more