- Daiichi Sankyo, Inc. (Bernards, NJ)
- …project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences ... 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
- Merck & Co. (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions. -Under the general scientific and administrative direction ... of Director in the CCFS group and working in conjunction...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study ... conventions. Reviews and submits DS Medical Coding synonym list update requests to the Associate Director of Medical Coding to ensure accuracy and consistency of… more
- 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
- AbbVie (Waltham, MA)
- …. Job Description As an Associate Director of Regulatory Affairs in Chemistry, Manufacturing, and Controls ( CMC ), you will collaborate ... and cell & gene therapies. You will be responsible for creating CMC regulatory strategies that facilitate first-pass approvals of regulatory submissions.… 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
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as the Associate Director , CMC Program Lead in Allogeneic Cell Therapies. You ... will be responsible to collaborate across Cell Therapy CMC functions and RA functions to deliver CMC pipeline and CMC platform projects. You will sit within… 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
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description As an Associate Director , Operations Strategy and Pipeline Leadership (OSPL) within the ... with internal and external stakeholders. + Stay updated on global CMC technical, regulatory , compliance developments, and industry practices. Qualifications… 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)
- …a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director , North America Regulatory Leader in Raritan, NJ. Remote ... & Johnson, we all belong. Key Responsibilities: + Key contributor to regulatory strategy plan, regulatory submission strategy, identifying submission risks,… 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …worldwide, with headquarters in Foster City, California. **Job Overview** As the Associate Director , Project Management, you will be assigned projects of ... among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC , Labeling, Advertising and Promotion, 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
- Merck (Rahway, NJ)
- …team environment with key stakeholders across the organizations such as Quality, Regulatory CMC , and technical functions, to ensure timebound progression of ... have solid understanding of integration and partnering for Pharmaceutical development/ CMC with Quality, Regulatory , Operations, Non-clinical, Clinical, and… 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
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking an enthusiastic ** Associate Director , Program & Portfolio Management** to drive programs forward at Regeneron Cell Medicines (RCM) through ... on programs that are in IND-enabling studies through clinical study execution. **As an Associate Director , Program & Portfolio Management at RCM, a typical day… more
