- J&J Family of Companies (Spring House, PA)
- …by generating hypotheses and investigative strategies. Accountable for global regulatory nonclinical documents and health authority responses to support clinical ... (L&A) opportunities. Collaborate proactively with Chemistry, Manufacturing and Controls ( CMC ) functions to assure drug substance quality. Actively participate in… more
- Parexel (Harrisburg, PA)
- …all aspects of laboratory equipment during audits Ensure compliance with all regulatory requirements (cGMP) and internal policies and procedures Required Skills and ... standard operating procedures (SOPs) About Parexel Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with… more
- Lilly (Philadelphia, PA)
- …life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory will leverage CMC technical knowledge and ... regulatory science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of… more
- Parexel (Harrisburg, PA)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure our client's ... regulatory leads in developing contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional project meetings and… more
- Merck (Harrisburg, PA)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... in business process mapping, gap analysis, and workflow optimization for CMC / regulatory authoring. + Practical knowledge of content models/structured content,… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …domestic/international travel. **Job Description** + Develop and implement global CMC regulatory strategies for late-stage development, marketing applications ... of regulatory submissions (IND/IMPD/NDA/MAA, post-approval supplements). Determine regulatory CMC content and scientific/technical requirements to ensure… more
- Parexel (Harrisburg, PA)
- …treatment options to patients. We are currently seeking a dedicated and detail-oriented ** Regulatory CMC Project Manager** to join a growing, dedicated client ... affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive… 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
- Sumitomo Pharma (Harrisburg, PA)
- …of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … 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 ... **Preferred Experience and Skills** + A candidate with experience in Regulatory CMC post-approval lifecycle management is preferred. OCMC \#LI - Hybrid Secondary… more
