- Gilead Sciences, Inc. (Foster City, CA)
- …create possible, together. **Job Description** ** Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs:** **_*This ... site based position located in Foster City, CA_** The Associate Director , Analytical Regulatory Science,...for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… 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 ... all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory...health, environment or politics or related degree and: + Associate Director : 15+ years of related experience… more
- Organon & Co. (Plymouth Meeting, PA)
- …Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… 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)
- …is required. + Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, presentation, ... or functions or outputs of this position. Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline small molecule… 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
- AbbVie (Worcester, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing ... + Participate in the planning/design, conduct, analysis, and interpretation of CMC studies and regulatory submissions. Participate in establishing departmental… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** Takeda Development Center Americas, Inc. is seeking an Associate Director , CMC Program Lead, Cell Therapies in Cambridge, ... and product quality improvement in Chemistry, Manufacturing & Control ( CMC ) processes; Employ technical project management principles (project planning, RACI,… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- WuXi AppTec (Natick, MA)
- …needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC ... drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof. With over… 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 ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...Proposal (RFP) through contract execution for clinical studies and CMC projects as well as ongoing governance with key… more
- Novo Nordisk (Boulder, CO)
- …are driving change. Are you ready to make a difference? The Position The Associate Director , Process Chemistry will be responsible for the design, development ... in 2021 to support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical...scaling of small molecules, oligonucleotide intermediates and API's. The Associate Director is expected to implement novel… more
- BeiGene (Emeryville, CA)
- **General Description:** The Associate Director , DP Commercial Small Molecule in External Supply Quality organization is responsible for ensuring the commercial ... cross functionally and collaboratively in BeiGene with eg Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU. + Provide quality… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …highly motivated and experienced Business Operations Leader to join our team. The Associate Director of Product Development (PD) Operations, reporting into the ... across the Global Product Development & Supply organization, for CMC development for both small and large molecules. Here...business questions across the enterprise. In this role, the Associate Director of PD Operations is responsible… more
- Abeona (Cleveland, OH)
- The Associate Director Quality Control (QC) will...overall QC operations + Assist in the preparation of CMC regulatory submissions + Interact with the ... oversee the operation of the QC Microbiology and Transport functions. The Director is responsible for supporting the QC testing, utility and environmental monitoring… more
- Vera Therapeutics (Brisbane, CA)
- Title: Associate Director , Project Management Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... Summary We are seeking a highly skilled and motivated Associate Director , Project Management. The ideal candidate...Project Management. The ideal candidate will work with the Regulatory team to develop project plans and to ensure… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director , Upstream MSAT **Location:** Framingham, MA **About the Job** We are an innovative global healthcare company with one purpose: ... you thought was possible. Ready to get started? The Associate Director position is part of the...responsible for preparing reports and other internal documentation for regulatory purposes. + Collaborate with MSAT and CMC… more
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