- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs. This position can be located in Spring House, PA; Horsham, PA; ... of development and commercialization. This person is responsible for developing global CMC regulatory strategies. The primary responsibility is to work on… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Ingelheim is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to join ... Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate ...requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs. + Support complex, non-standard… more
- 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
- Organon & Co. (Plymouth Meeting, PA)
- … Principal Scientist ( Associate Director ) is responsible for Regulatory Chemistry, Manufacturing and Controls ( CMC ) aspects of clinical phase through ... **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
- 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
- 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
- AbbVie (Worcester, MA)
- …Instagram, YouTube and LinkedIn. Job Description Position will be responsible for CMC leadership and project management for existing and new biologics projects from ... manufacturing, process development and process characterization to management and to regulatory agencies. *Prepare and review regulatory briefings and… more
- Sumitomo Pharma (Columbus, OH)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs** . The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… 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
- 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- We are seeking an Associate Director within the Formulation Development Group of Regeneron Pharmaceutical Inc. at Tarrytown, NY. This role will lead clinical and ... and captures efficiencies. + Key contributor to high quality CMC regulatory filings, approvals, and commercialization of drug products. Ensures compliance… more
- Takeda Pharmaceuticals (Lexington, MA)
- …to the best of my knowledge. **Job Description** **Objective / Purpose:** As an Associate Director in Analytical Development, it is expected that the individual ... regulatory submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide guidance to… more
- Editas Medicine (Cambridge, MA)
- …as a passion to lead, mentor and influence people. Characterizing Your Impact: As the Associate Director , LNP Process Development you will: + Lead and grow a ... also be a key contributor to the overall program CMC strategy. This role requires strong technical expertise in...stakeholders and external partners + Author and review of regulatory submissions, technical reports, SOPs and work instructions +… 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
- Bristol Myers Squibb (San Diego, CA)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals . The Director / Associate Director of Radiochemistry will lead the Discovery ... modalities such as peptides, small molecules, and antibodies. The Director / Associate Director will also be...cross-functional teams. + Ability to partner effectively with clinical, regulatory , CMC development, biology, and DMPK teams… more
- Merck (North Wales, PA)
- …& Division organization of our company. ** ** **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more