- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** We are seeking an Associate Director , Regulatory Affairs CMC candidate to sit at our Foster City, ... CA site. **Responsibilities:** + The CMC Regulatory Affairs Associate Director at Gilead is responsible for providing strategic direction, operational… more
- Boehringer Ingelheim (Ridgefield, CT)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The Associate Director , US Product CMC Regulatory Affairs is responsible for the ... and post marketing reports per US FDA regulations. The Associate Director , US Product CMC Regulatory Affairs acts as primary internal contact for all US… more
- Takeda Pharmaceuticals (Boston, MA)
- …knowledge. **Job Description** **OBJECTIVE / PURPOSE** + Providesprogram leadership and develops CMC regulatory strategy in support of global vaccine programs in ... CMC regulations and guidelines by applying interpersonal skills and expert regulatory CMC knowledge to identify, communicate, address, and overcome challenges… 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
- AbbVie (North Chicago, IL)
- …Demonstrate strong negotiating, influencing, and leadership skills. + Manages completion of CMC regulatory submission documentation for a limited number of ... the primary Drug Product Development (DPD) representative to interface with the CMC Regulatory group. Lead CMC project teams in planning, preparation, review… 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
- Amneal Pharmaceuticals (Piscataway, NJ)
- …and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical ... compliance with FDA, EMA, and Health Canada regulations. Assess regulatory impact of changes in CMC procedures...regulations. Assess regulatory impact of changes in CMC procedures and oversee internal regulatory guidance… more
- J&J Family of Companies (Raritan, NJ)
- …if approved by the Company. **We are searching** **for the best talent for** ** Associate Director , North America Regulatory Leader** **to** **be in Raritan, ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job… more
- Otsuka America Pharmaceutical Inc. (Rockville, MD)
- **Job Summary** Associate Director , Quality Control, Biologics is responsible for late development stage through commercial biologic products including product ... Analytical Quality by Design. + Experience in reviewing and approving analytical-related CMC sections of BLA/MAA regulatory submissions. + Strong leadership,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Product Development Princeton, NJ, USA Req #448 Thursday, March 6, 2025 Looking for a chance to make a meaningful difference in the oncology ... the oncology space this is the role for you. Position Summary: + The Associate Director , Product Development will be responsible for product development, scale… 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 captures efficiencies. + Key contributor to high quality CMC regulatory filings, approvals, and commercialization of drug products. Ensures compliance… more
- AbbVie (North Chicago, IL)
- …talented leader with experience and expertise in developing drug products for a Associate Director /Principal Research Scientist II/ position to join our team ... The Drug Product Design and Development (DPDD) group within the Small Molecule CMC organization at AbbVie is responsible for the design and development of drug… more
- Lilly (Indianapolis, IN)
- …who are determined to make life better for people around the world. The Associate Director / Director will operationalize content strategy central to portfolio ... demands and external expectations. This role will report to the Sr. Director , Global Scientific Communications (GSC) - Portfolio & Capability ( Regulatory … more
- Merck (West Point, PA)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure development of robust ... regulatory posture + Demonstrated working knowledge of FDA, ICH, and other regulatory requirements for CMC . Strong experience in safety and environmental… more
- University of Southern California (Los Angeles, CA)
- cGMP Associate Director , Process DevelopmentApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/cGMP- ... cell and gene therapies and other biological products for internal/external users. The Associate Director of Process Development (cGMP) is responsible for all… more
- AbbVie (North Chicago, IL)
- …/ week* This position can be hired based on the following qualifications below: Associate Director , Clinical Pharmacology: + PhD with typically 4+ years of ... groups to provide a unified clinical pharmacology position to clinical, CMC and regulatory teams. + Authors scientific publications and present at national and… more
- Merck (Rahway, NJ)
- …Reporting to the Director of Packaging Commercialization, the Associate Director , Engineering, Packaging Commercialization will lead packaging development ... prior experience developing and commercializing new products on cross-functional teams. The Associate Director will be accountable for the definition and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Program Management in our Cambridge, MA office. At Takeda, we ... have responsibility for line management of Sr. Manager and/or Associate Director level GPMs as well as...within related functions (eg Clinical Science, Clinical Operations, Research, Regulatory , CMC , Marketing) + Minimum of 5… more
- Merck (West Point, PA)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies… more
- Novo Nordisk (Lexington, MA)
- …research with line-of-sight for drug development value chain including CMC and regulatory paths. Relationships Reports to Senior Director of GE and RNA ... driving change. Are you ready to make a difference? The Position As the Associate Director of Genome Editing, you will lead a team of four scientists based in… more