- Regeneron Pharmaceuticals (Cambridge, MA)
- Regeneron Cell Medicine is looking for an Associate Director in Regulatory CMC for biologics who will be responsible for the development and submission of ... position you will be responsible for driving the development of innovative CMC regulatory strategies and the preparation and submission of high‑quality CMC … more
- Regeneron Pharmaceuticals (Troy, NY)
- We are seeking a highly motivated and experienced Senior CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC Regulatory ... for effectively communicating complex scientific information. As a Senior CMC Regulatory Sciences Specialist, a typical day might include the following:… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining ... This position will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining the global… more
- Lilly (Philadelphia, PA)
- …support communities through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation and delivery of ... high-quality CMC regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed products globally. **Responsibilities:** +… more
- **Kelly Science has an Immediate opening for a Senior CMC Regulatory Sciences Specialist for our growing client near St. Louis, MO** Full-time Direct Hire Hybrid ... Compliance & Submissions** + Prepare, review, and submit high-quality postapproval CMC regulatory submissions and related correspondence to the FDA/CVM. +… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Lilly (Indianapolis, IN)
- …manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory ... + Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, acquiring… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop post approval and lifecycle regulatory strategies… more
- Chiesi (Boston, MA)
- …of a regulatory submission. + Execute preparation of timely responses to CMC regulatory questions in coordination with Subject Matter Experts (SME) as ... Maintain submission information according to the document management system, track regulatory CMC commitments & timelines for specific projects/products/markets… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as follows: + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products as ... to guide the team to define and drive strategy for CMC regulatory dossier content and reviews this content for conformance with established requirement.… more
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