- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls ( CMC ) quality and ... for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the following +… more
- Lundbeck (Deerfield, IL)
- Director Global Regulatory Affairs CMC - Remote Opportunity Requisition ID: 5582 Location: Deerfield, Illinois, US Do you want to join a team where the ... of the product (IND/CTAs, NDAs/BLAs, Marketing applications). This role will provide CMC regulatory support and guidance for assigned projects and interfaces… more
- Gilead Sciences, Inc. (Foster City, CA)
- …be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. ... Gilead and help create possible, together. **Job Description** The Associate Director , Analytical Regulatory Science, collaborates with product development,… 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- Small Molecule...CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.… more
- AbbVie (North Chicago, IL)
- …abreast of developments in global technical, regulatory and compliance arena and industry practice. + Apprises CMC Management of plans and risks through ... strategy is closely aligned with the clinical and regulatory development strategy. May lead multiple PPDST/ CMC teams from GLP tox through IND and cPoC towards… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …8-10 years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry ... contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to...and 4+ years direct or related CMC regulatory experience + Successful track record in preparation, management… 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 ... of experience with at least 2 + years within CMC Development in the pharmaceutical/biopharmaceutical industry preferred - 4 or More Years Ability to prioritize… more
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... approval of asset in region. + Stay updated on industry trends, technological advancements, and regulatory changes...projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage… more
- AbbVie (Florham Park, NJ)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical ... + Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental… more
- Frontier Medicines (South San Francisco, CA)
- Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San ... of our team, reporting directly to the Head of CMC , you'll play an integral role in advancing our...passionate about making a tangible impact in the pharmaceutical industry , we invite you to join us in this… more