- Boehringer Ingelheim (Ridgefield, CT)
- …Boehringer Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to ... Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director...requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs. + Support complex, non-standard… 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
- Actalent (Boston, MA)
- …to Boston area to accommodate flexible hybrid schedule Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member ... to agency questions, and maintenance activities. + Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams… more
- Merck (North Wales, PA)
- …/ Director responsibilities include but are not limited to:** + Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within ... **Job Description** Under general supervision of an Executive Director /Senior Director , the Principal Scientist /...+ Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of… 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
- Vera Therapeutics (Brisbane, CA)
- …experienced, fast-paced and collaborative team. The Senior Manager will report to the Senior Director of Regulatory CMC and will be responsible for working ... Job Title: Senior Manager, Regulatory CMC Location: Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on… 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
- Lilly (Indianapolis, IN)
- … CMC technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the ... development strategies and submission content + Makes risk-based decisions on CMC regulatory strategies impacting product submissions across geographies and… 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
- 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
- AbbVie (Irvine, CA)
- …and readiness for launch. They are responsible for communicating development and regulatory risks and seeking feedback from CMC leadership. Key Responsibilities: ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. + Multiple product development experiences… more
- AbbVie (North Chicago, IL)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Product Development will use their breadth of ... CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. + Multiple product development experiences… 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
- 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
- Lilly (Philadelphia, PA)
- …and cost targets. + Collaborate with cross-functional team leaders, including development, CMC regulatory , manufacturing, and supply chain teams, to ensure ... and supply projects and programs. + Advanced understanding of cGMPs and CMC regulatory requirements + Ability to manage people and drive engagement among teams.… more
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