- Gilead Sciences, Inc. (Foster City, CA)
- …will assume a full-time employment role in the capacity of Senior Associate in Gilead's Regulatory Affairs CMC department. **Job Description:** + ... countries worldwide, with headquarters in Foster City, California. **Sr. Associate , CMC Regulatory Affairs -...detail. Work is performed under limited direction of a senior Regulatory Affairs professional. **Minimum Qualifications:** +… 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...effectively communicate the status of ongoing CMC regulatory projects to cross-functional teams and senior … 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
- Amgen (Washington, DC)
- …regulatory strategy, risks and issues to Regulatory and Operations senior management. The CMC Product Lead coordinates communication, collaboration, and ... Product Lead is responsible for execution and/ or coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to… 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 ... CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence, a typical...health, environment or politics or related degree and: + Associate Director: 15+ years of related experience in regulated… 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...thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required + Ability to travel domestically… more
- Ascendis Pharma (Palo Alto, CA)
- …and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. + Contribute to internal regulatory policies ... a dynamic workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …candidate will be responsible for authoring protocol and reports and contributing to CMC section of regulatory submissions. The ability to analyze, interpret ... work effectively under general supervision and contribute to team efforts to support CMC Development projects. **Note: This is located in Research Triangle Park R&D… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a ** Senior Manager/ Associate Director of Clinical Pharmacology** to join us in our mission to discover and develop drugs that improve ... stakeholders including DMPK, translational medicine, clinical development, clinical operations, regulatory , CMC , and project management to ensure completion… more
- Takeda Pharmaceuticals (Boston, MA)
- …You will also prepare and coordinate completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports ... As part of the Analytical Development team, you will report to Associate Director, Analytical Development. **How you will contribute:** + Develop and leverage… more
- BeiGene (Emeryville, CA)
- …Will work cross functionally and collaboratively in BeiGene with eg Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. + Provide ... **General Description:** The Associate Director, DP Commercial Small Molecule in External...and GxP guidelines + Work with Clinical Product Quality, regulatory and CMC to establish Process Performance… more
- Takeda Pharmaceuticals (Lexington, MA)
- …BLA/MAA regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide ... the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual will… more
- Taiho Oncology (Princeton, NJ)
- Associate Director, Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... Proposition: Join our dynamic and expanding mid-size company in the role of Associate Director, Outsourcing and Vendor Management. Your expertise will play a pivotal… more
- Novo Nordisk (Boulder, CO)
- …new laboratory completed in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi ... the Department The Boulder Site is home to the specialized technical operations/ CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as the… more
- Merck (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Key Responsibilities** Associate II, Global External Manufacturing, Small Molecule Drug Substance (DS) ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- CSL Behring (King Of Prussia, PA)
- …knowledge in drug research, development and manufacturing processes of pharmaceuticals ( CMC , non-clinical, clinical, and regulatory ).** **Expert level skillset ... used to treat serious and often rare conditions. Could you be our next Associate Director, R&D Project Planning Capability Lead? This position is located in our King… more
- Merck (North Wales, PA)
- …integrating strategic and tactical input from diverse disciplines (eg, clinical, regulatory , market access, manufacturing, CMC , commercial, and other areas) ... Research & Division organization of our company. **Position Description/Summary:** The GPAM Associate Director, Project Manager, is a core member of Early Drug… more
- Merck (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... of Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists. The successful candidate will effectively… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience within related functions (eg Clinical Science, Clinical Operations, Research, Regulatory , CMC , Marketing) + 3-5 years program management experience ... analyses to communicate program development progress, opportunities, and risks to Senior & Executive Management. Responsible for leading preparation efforts for… more