- Bristol Myers Squibb (Princeton, NJ)
- …to build/maintain database to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for ... participating/leading HA meetings); and/or post-approval submissions. In this role, the GRS-CMC Associate Director , Biologics will serve as the primary… more
- Gilead Sciences, Inc. (Foster City, CA)
- …countries worldwide, with headquarters in Foster City, California. ** Associate Director - Material Science** **(Pivotal & Commercial Biologics )** **Role ... with industry best practices, guidelines, and emerging trends. Knowledgeable about regulatory requirements and processes related to biologics development,… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- Takeda Pharmaceuticals (Columbus, OH)
- …true to the best of my knowledge. **Job Description** **About the role:** ** Associate Director , Nonclinical Regulatory Writing and Submission Support,** ... Here, you will be a vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing and Systems (NRWS)… more
- Novo Nordisk (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions + Serve ... in drug development required + Demonstrated knowledge of global regulatory requirements for drugs and biologics + Proven ability to develop robust regulatory … more
- Regeneron Pharmaceuticals (Troy, NY)
- …and/or biologics . + Lead and facilitate interactions with global regulatory authorities (eg, meetings, IR responses, inspections). + Perform final review and ... will be responsible for leading the development and execution of global regulatory strategies for biologic products and combination products for the product… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director where you will evaluate the biological activity of the ... potential therapeutics candidates generated in global biologics and select the best candidates for further preclinical and clinical development. Global Biologics… more
- Merck (Rahway, NJ)
- …as the biopharmaceutics support for the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the ... in bioperformance of formulations The Director will report to the Executive Director of Biologics and Biopharmaceutics, have 8-10 direct reports composed of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... regulatory process optimizations on relevant topics. **Responsibilities** - Supports CMC regulatory compliance activities for portfolio biologics to meet US,… more
- Bristol Myers Squibb (Summit, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Title: Associate Director , Cell Therapy Comparability** **Location: Summit, NJ or ... your career, and the ability to help patients are incredible. The ** Associate Director , Cell Therapy Comparability** will lead comparability programs and… more
- AbbVie (North Chicago, IL)
- …Translational Pharmacokinetics and Clinical Pharmacology group at AbbVie is seeking for an Associate Director . As a member of multidisciplinary teams, this role ... engagement strategy for assets in eyecare, aesthetics, and neurotoxin portfolios. The Associate Director of Clinical Pharmacology will also establish innovative… more
- Charles River Laboratories (Memphis, TN)
- … Testing Solutions** With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects ... a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit...and over 200 licenses products are supported by our biologics testing solutions team. **About Charles River** Charles River… 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 ... submissions. Knowledgeable in European, Japanese, Chinese and US CMC regulatory requirements for Biologics + Represents AD and provide guidance to PST teams by… more
- Merck (Rahway, NJ)
- …Operations. We are seeking a highly motivated individual for the role of Associate Director , Tech Transfer Leader in Large Molecule Technology Transfer within ... end-to-end scope includes Drug Substance and Drug Product for all large molecules. Associate Director is expected to contribute to ongoing business process… more
- Merck (West Point, PA)
- **Job Description** The Associate Director , Technical Operations, is responsible for the management and oversight of a team providing technical support for a ... management team and installation of robust CAPAs, among other related duties. The Associate Director will have overall responsibility for the performance and… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **PURPOSE AND SCOPE OF POSITION:** The Associate Director , CTF Digital Plant IT Quality at Devens Cell ... COMPETENCIES: Knowledge, Skills, and Abilities** + Thorough knowledge of regulatory computer system validation requirements including FDA, EMA, and Worldwide… more
- J&J Family of Companies (Horsham, PA)
- Associate Director , Temperature Strategy & Execution - 2406177829W **Description** Johnson & Johnson Innovative Medicine Research & Development (JJIM R&D), part ... of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director , Temperature Strategy & Execution within Clinical Supply Chain (CSC). The… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director - Site Planning Global Process Leader (GPL) ... planning processes and digital capabilities are delivering the needs of the Biologics and Pharmaceutical commercial business units . **Key Responsibilities** Forge a… more
- Bristol Myers Squibb (Summit, NJ)
- …+ Advanced Degree in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience with demonstrated ... covering all therapeutic modalities, including small molecules, traditional and complex biologics and next gen cell therapies. All therapeutic areas are supported.… more
- AbbVie (North Chicago, IL)
- …while effectively managing local and global interfaces across Small Molecule and Biologics Analytical R&D functions (SMARD/BARD), CMC Regulatory Affairs (RA), ... functional vision into actionable strategies. + Stays current on global regulatory expectations and trends (via guidelines, GMPs, trade organizations, and other… more
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