- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. ** 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 Biologics portfolio.… more
- Taiho Oncology (Pleasanton, CA)
- …Value Proposition: Join our dynamic and expanding mid-size oncology company in the role of Director , Regulatory CMC , reporting directly to Executive ... Director , Regulatory Affairs CMC Pleasanton, CA, USA...Director , Regulatory CMC . Your expertise will play a pivotal and visible role in advancing… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director , Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... and new people to make a difference with. **The opportunity** The Senior Director , Regulatory Affairs CMC is responsible to manage and help develop … more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. **Senior Advisor/ Director , Global Regulatory Affairs - CMC , Small Molecules** At Eli ... them all over the world. The Senior Advisor/ Director in Global Regulatory Affairs - CMC Small Molecules will leverage CMC technical knowledge and … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you will provide program ... leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development. You will represent the vaccine regulatory … 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
- Merck (Rahway, NJ)
- …for managing a team of CMC professionals and ensuring high rigor in CMC regulatory strategy as well as delivery of high-quality CMC submissions ... will play a critical role in driving alignment and execution globally across Regulatory CMC , GRACS, our Research and Development Division (R&D), our… more
- Takeda Pharmaceuticals (Boston, MA)
- …GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals. **How you ... regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM… 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
- 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 ... with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives. You will also influence… more
- Amicus Therapeutics (Marlow, OK)
- Associate Director CMC RA Location Marlow, UK Requisition ID 2246 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1290) Job Brief Associate Director CMC RA Amicus Therapeutics is a global,… more
- AbbVie (North Chicago, IL)
- … CMC activities with respect to science, technology, quality, regulatory /compliance requirements, budget and resources. + Excellent communication, leadership and ... and Device Strategy Teams (PPDST) and Chemistry, Manufacturing and Controls ( CMC ) teams of functional representatives from various departments and divisions.… more
- BeiGene (San Mateo, CA)
- …stage through clinical proof of concept. + Lead cross-functional team to author CMC / quality sections of regulatory submissions (INDs/CTDs). + Building scope and ... processes and analytics for cell therapy products. + Assembling relevant CMC data and authoring regulatory filing documents ( CMC sections) and responses to… 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
- Actalent (Bridgewater, NJ)
- …in both topical and oral dose formulation development. * Experience in preparing CMC components of briefing books, regulatory responses, and IND modules. * ... dossiers through multiple rounds * The role is responsible for the overall CMC package * Experience working across borders and internationally is helpful but not… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …of our academic community. **Description** The Goizueta Business School is seeking a Director to lead the career development and recruiting efforts for the newly ... in Management (MiM) Program. Reporting to the Assistant Dean & Executive Director for the Undergraduate Career Management Center and collaborating closely with the… more
- Frontier Medicines (Boston, MA)
- 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...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** ** Director , Cell Culture Process Development - Pre-Pivotal Biologics CMC Development - Foster City, CA** At Gilead, we're creating a healthier ... Join Gilead and help create possible, together. **Job Description** The Director , Cell Culture Process Development (Pre-Pivotal) will be responsible for leading… more
- AbbVie (South San Francisco, CA)
- …LinkedIn. Job Description Position Description: For the Biologics Drug Product R&D Director position, we are seeking a highly motivated, experienced leader to lead ... of all functional deliverables including reports and applicable quality and regulatory documents. + Implement and manage functional processes and workflows for… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** The EACD department develops new CMC paradigms for more effective and efficient NCE development and for advancement of NCE-like Alternative Medicinal ... Therapeutic Product (ATMP) projects. The Associate Director , Analytical/QC will be responsible for leading activities related to Analytical Development/Quality… more