- J&J Family of Companies (Columbus, OH)
- Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory ... of development and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is to work on… more
- Gilead Sciences, Inc. (Foster City, CA)
- …liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. ** Director , CMC Regulatory Affairs - Biologics** **Key ... Responsibilities:** The Director , CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more molecules in the… more
- Lilly (Philadelphia, PA)
- …determined to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global ... CMC regulatory activities for Lilly/Avid diagnostic radiopharmaceutical products. This includes...radiopharmaceutical products. This includes the delivery of all relevant CMC regulatory submissions in addition to assessing… more
- Amgen (Thousand Oaks, CA)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global CMC ** **What you will do** ... of regulatory experience **Preferred Qualifications:** + Substantial experience leading CMC Regulatory Affairs strategy and execution for biologic products… more
- Actalent (Boston, MA)
- *Gene therapy experience preverred* Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and compliance ... policy and standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the… more
- Actalent (Boston, MA)
- …compliance requirements. Reviews proposal in final stage prior to Research Administrative Director signature and submission to sponsor. + Assists PI with posting ... support to RAD on special projects as necessary. + Works with Research Administrative Director , Research facilities and PI with on boarding of new lab staff and lab… more
- Takeda Pharmaceuticals (Lexington, MA)
- … where you will independently develop and lead the execution of regulatory CMC investigational, registration and/or pos-approval strategies for assigned products ... CMC team, you will report to the Senior Director GRA CMC and work cross functionally...Guide the team to define and drive strategy for CMC regulatory dossier content and reviews this… more
- Regeneron Pharmaceuticals (Troy, NY)
- …goals, and current policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio of CGT products ... industry experience including a minimum of 5 years of relevant CMC Regulatory experience including experience in the field of cell and gene… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Scientist (Associate Director ) is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product… more
- Takeda Pharmaceuticals (Boston, MA)
- …the Regulatory Affairs CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will ... therapies to patients worldwide. Join Takeda as a Senior Director , GRA CMC Pharmaceuticals Development Portfolio Lead...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** **Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs:** **_*This ... be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. **Job… more
- Takeda Pharmaceuticals (Boston, MA)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device ... product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC ; international experience is a plus + Experience working… more
- Organon & Co. (Plymouth Meeting, PA)
- …the Associate Principal Scientist (Associate Director ) is responsible for Regulatory Chemistry, Manufacturing and Controls ( CMC ) aspects of clinical phase ... **Job Description** **The Position** Reporting to the Director in Organon Regulatory Chemistry, Manufacturing...colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical… more
- AbbVie (North Chicago, IL)
- …and ensures CMC strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple PPDST/ CMC teams from GLP tox through ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. *Multiple product development experiences… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with 8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... experience and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management of review and approval of NDA/MAA/BLA… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead an experienced team ... responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory documents. Reporting to the VP CMC Strategy and… more
- AbbVie (North Chicago, IL)
- …is required. + Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, presentation, ... (https://www.tiktok.com/@abbvie) . Job Description Purpose Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …project development preferred - 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for ... areas centered around rare diseases and immune disorders. **Summary** CMC Lead is responsible for supporting the overall ...CMC Lead is responsible for supporting the overall CMC strategies within projects, and manage project teams. The… more