- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The 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 all relevant… 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
- 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 ** Reporting to the Director in Organon Regulatory CMC , the Associate Principal Scientist is responsible for developing and ... the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed. **R** **equired… more
- Merck (West Point, PA)
- …+ Prepare clear statistical content for Chemistry, Manufacturing, and Controls ( CMC ) documentation; assist with regulatory queries using sound statistical ... **Job Description** **Sr. Statistician - Chemistry, Manufacturing, and Controls ( CMC )** R3 Under the general supervision of a senior staff member in Center for… 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
- Bausch + Lomb (Harrisburg, PA)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... business outcomes. **Responsibilities:** + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical/non-clinical, labeling, adpromo… more
- Merck (Harrisburg, PA)
- …development through commercialization, with practical insight into how these operations generate CMC regulatory content + Understanding of CMC operations, ... transfer of process and product knowledge with reduced error rates Digital CMC will implement digital solutions to install the foundational capabilities needed to… more