- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** **Sr Associate , Regulatory Affairs , CMC ** **Foster City, ... teams. + Develop, implement, and document policies and procedures within the CMC regulatory affairs department under supervision of manager. Participates in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …in more than 35 countries worldwide, with headquarters in Foster City, California. **Sr. Associate , CMC Regulatory Affairs - Biologics** Gilead Sciences ... employment role in the capacity of Senior Associate in Gilead's Regulatory Affairs CMC department. **Job Description:** + Responsible for the preparation… more
- J&J Family of Companies (Horsham, PA)
- Johnson & Johnson is recruiting for an Associate Director, CMC Regulatory Affairs . This position can be located in Spring House, PA; Horsham, PA; ... strategies as new data become available. + Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance… more
- Organon & Co. (Plymouth Meeting, PA)
- …Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal Scientist ( ... Associate Director) is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects...colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** ** Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs :** ... site based position located in Foster City, CA_** The Associate Director, Analytical Regulatory Science, collaborates with...for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure… more
- Organon & Co. (Plymouth Meeting, PA)
- … Associate Principal Scientist ( Associate Director) is responsible for Regulatory Chemistry, Manufacturing and Controls ( CMC ) aspects of clinical phase ... with internal colleagues and Contract Research & Manufacturing Organizations to enable regulatory CMC strategies and execution of clinical study phase and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the ... years pharmaceutical industry experience with 4+ years direct or related CMC regulatory experience or + PhD. with 6-8 years pharmaceutical industry experience… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director, Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and… more
- Randstad US (Newbury Park, CA)
- regulatory affairs senior associate . + newbury park , california (remote) + posted october 30, 2024 **job details** summary + $35 - $40.41 per hour + ... Authority correspondence + Data Management Point of contact between Regulatory Representatives / CMC , publishing teams and...8 years of experience skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory … more
- System One (Florham Park, NJ)
- …+ Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs , clinical operations, and quality assurance in a ... Senior Regulatory Operations Associate Contractor (Publishing) Must...pharmaceutical environment. + Proven experience in preparing and submitting regulatory documents, including nonclinical, clinical, CMC , DMF,… more
- University of Maryland, Baltimore (Baltimore, MD)
- …in the MS in Regulatory Science program, with a focus on introductory and regulatory affairs aspects of the program, as well as another aspect of the program ... AREAS OF EXPERTISE AND EXPERIENCE_* Regulatory science, including introductory and regulatory affairs aspects, as well deep knowledge in another aspect (eg… more
- Taiho Oncology (Princeton, NJ)
- …such as clinical operations, data management, Pharmacovigilance Operations, Medical Writing and Regulatory Affairs is a plus. + CPM or CPIM certification ... Associate Director, Outsourcing & Vendor Management Pleasanton, CA,...CROs, Central Lab, IRT, IRBs, Wearables, Investigators sites, Medical Affairs , HEOR, CMC and other related ancillary… more
- Lilly (IN)
- …collaborate with team members across functions including but not limited to clinical operations, CMC , regulatory affairs , and QA. + Working knowledge of ... through philanthropy and volunteerism. ** ** **Position Summary:** The Associate Director, Clinical Supply Management has responsibility for the end-to-end… more
- Randstad US (North Billerica, MA)
- …and make it happen skills: HPLC, SOP, GLP (Good Laboratory Practice), Regulatory Affairs Operations Equal Opportunity Employer: Race, Color, Religion, Sex, ... associate research scientist. + north billerica , massachusetts...Operations, including: InfoLinx archiving systems, Radionuclide databases, SOP systems, CMC submission document preparation within R&PD, training modules and… more