- 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
- 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
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director , Regulatory Affairs - West Chester, PA Date: Apr 24, 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
- 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 (Cambridge, MA)
- …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
- Merck (Columbus, OH)
- …on time, every time, across the globe. **Position Responsibilities:** + The Associate Director is responsible for performing comprehensive and detailed GMP ... with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract… more
- AbbVie (Barceloneta, PR)
- …@abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Quality provides leadership and direction to the Quality ... Function they are responsible for within Operations. This Associate Director , Quality is responsible for the effective implementation of AbbVie Quality Systems… 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
- 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
- Bristol Myers Squibb (New Brunswick, NJ)
- …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
- Teva Pharmaceuticals (West Chester, PA)
- Associate Director - Biomarker and Metabolism Analytics Date: Apr 26, 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
- Merck (Columbus, OH)
- …component of decision-making at ouor company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. This ... Associate Director will work with scientists within...+ Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics ,… more
- Actalent (Paramus, NJ)
- MUST BE ON-SITE IN PARAMUS, NJ 5 DAYS/WEEK The Associate Director , Clinical Operations is responsible for oversight of US clinical development providing vision, ... leadership, and mentoring of staff. The Associate Director is also a valuable team...procedures o Ensure successful execution of projects according to regulatory guidelines, provide technical leadership, and facilitate effective internal… 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
- J&J Family of Companies (Titusville, NJ)
- 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
- AbbVie (Worcester, MA)
- …YouTube and LinkedIn. Job Description AbbVie Bioresearch Center (ABC) is hiring an Associate Director Automation & Manufacturing Systems position to lead the ... working in a proactive and motivating team environment. The Associate Director Automation & Manufacturing position will...opportunity to lead a technical team within a multi-product biologics manufacturing facility. In this role, as head of… more