- J&J Family of Companies (Horsham, PA)
- …located in Horsham, PA; Spring House, PA; Titusville, NJ; or Raritan, NJ. The Director, CMC Regulatory Affairs Biologics New Modalities will lead a team of ... CMC regulatory professionals and will be responsible for development, implementation, and maintenance of global CMC regulatory strategies for innovative… more
- Sanofi Group (Swiftwater, PA)
- …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
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... searching for the best talent for a Distinguished Scientist, CMC Team Leader, Proteins to be in Malvern, PA...dynamics is required + Experience in setting development and regulatory strategies for products in development is required +… more
- J&J Family of Companies (Malvern, PA)
- …the identification and mitigation of CMC risks, the completion of required CMC regulatory documents and responses, creation and adherence to budget and ... **We are searching for the best talent for a** **Distinguished Scientist, CMC Team Leader, Protein Conjugates** **to be located in** **Malvern, PA or… more
- Organon & Co. (Plymouth Meeting, PA)
- **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. (Plymouth Meeting, PA)
- …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. (Plymouth Meeting, PA)
- … 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
- Deloitte (Pittsburgh, PA)
- …(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
- Merck (West Point, PA)
- …and influences process demonstration and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC ... transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group… more
- J&J Family of Companies (Spring House, PA)
- …and operate efficiently in times of ambiguity. + Previous experience working in a CMC or regulatory setting. + Previous experience with technology transfer of a ... reproducibility, accessibility to team members, and compliance with any regulatory requirements. + Excellent presentation, verbal communication, and scientific/technical… more