- Takeda Pharmaceutical (Lexington, MA)
- …help manage departmental and cross-functional teams occasionally.You will report to The Associate Director of QC Support.How you will contribute:Influence the ... leadership, including, motivate, and lead technical rigorKnowledge of cGMP and other regulatory requirements related to manufacturing of biologics and monoclonal… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Gilead and help create possible, together. **Job Description** **Key Responsibilities** Associate Director , Global External Manufacturing Biologics ensures ... external contract manufacturing network, while ensuring compliance with cGMP, regulatory requirements, and environmental, health, and safety legislations. This… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …pharmaceutical manufacturing to cGMP standards including extensive knowledge of regulatory guidelines and validation practices + Working knowledge of pharmaceutical ... development and commercialization processes. + Knowledge of suppliers, industry trends and emerging players in global pharmaceutical manufacturing services + Strong presentation and communication skills both, oral and written - Fluency in English. Required… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... for the advertising and promotion of prescription drugs and biologics . Essential Functions + Represents Global Regulatory ...and biologics . Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of… 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
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - West Chester, PA Date: Mar 26, 2024 Location: West Chester, United States, 1938 Company: Teva Pharmaceuticals Job ... difference with. **How you'll spend your day** As the Associate Director , Regulatory Affairs you...teams + Minimum 3 years of experience working with biologics /biosimilars + Minimum 3 years of experience working with… more
- Sanofi Group (Bridgewater, NJ)
- … environment and updating of standards and processes related to drug and biologics regulations + Ensure that respective regulatory team members have the ... the job** **Our team** The team is involved in developing and executing regulatory strategies for Tzield in life cycle development stages and post marketing to… more
- Sanofi Group (Bridgewater, NJ)
- … environment and updating of standards and processes related to drug and biologics regulations + Ensure that respective regulatory team members have the ... **Main responsibilities:** + Leads the US regulatory activities. + As a key member of...+ Understanding of clinical development of drugs and/or innovative biologics products + Demonstrated significant leadership experience with driving… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... Industry Guidelines for the advertising and promotion of prescription drugs, biologics , and devices. **ESSENTIAL FUNCTIONS** + Provide regulatory leadership… more
- Novo Nordisk (Princeton, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director , Global Regulatory Portfolio Lead. Essential Functions + Serve as ... in drug development required + Demonstrated knowledge of global regulatory requirements for drugs and biologics + Proven ability to develop robust regulatory … more
- Charles River Laboratories (Memphis, TN)
- Associate Director Biomanufacturing Req ID #: 222580 Location: Memphis, TN, US, 38118Memphis, TN, US, 38118 For 75 years, Charles River employees have worked ... feel passionate about. **Job Summary** Reporting to the Sr. Director Operations, the Associate Director ,...Demonstrates initiative to remain apprise of relevant industry and regulatory trends **About Biologics Testing Solutions** With… 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 (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Scientific Associate Director , DMPK Project Representative** Challenging. Meaningful. ... across the globe. PCO is looking for a Scientific Associate Director to join the Dev DMPK...activities of multiple projects; be responsible for preparation of regulatory dossier/responses; and assist in developing strategy for the… more
- AbbVie (Worcester, MA)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Quality Control provides leadership and direction to the ... Quality Function they are responsible for within Operations. This Associate Director , Quality Control is responsible for the effective implementation of AbbVie… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director is responsible for achieving and maintaining qualification/certification status through robust ... a broad-based expertise of cGMP's, Organon Policies, Procedures and Guidelines, regulatory requirements, etc. that are pertinent to the pharmaceutical industry… more
- Merck (Millsboro, DE)
- **Job Description** ** Associate Director , Animal Services** **About the Job** Animal Health in Millsboro Delaware seeks to add an Attending Veterinarian in the ... role of Associate Director . This position will have overall...other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory… more
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Associate Director (AD) Quality Product Lead (eg, QPL, Quality ... Quality representative for the lifecycle of commercial products/brands for the Biologics /Sterile Fill and Pharma business units. The QPL, Product Quality, will… more
- BeiGene (Emeryville, CA)
- …clinical and clinical pharmacology sections of INDs, NDAs, BLAs, MAAs and other regulatory submission documents. The Associate Director , Medical Writing is ... **General Description:** The Associate Director , Medical Writing is responsible...biologics development, clinical research, study design, biostatistics, and regulatory affairs (eg, FDA and ICH guidelines for various… more
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director - Biomarker and Metabolism Analytics Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: Teva ... group at the Teva West Chester, PA site has an opening for Associate Director with strong experience in biomarker method development and qualification/validation… more
- CSL Behring (King Of Prussia, PA)
- The Associate Director of US Market Access - New Products will lead US value, access, pricing, and reimbursement strategy in preparation for the launch of ... strategy, access strategy, reimbursement planning, and early account engagement. This Associate Director is responsible for developing and executing the… more
