- Parexel (Sacramento, CA)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios - Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant - Proven success in preparing regulatory… more
- Parexel (Sacramento, CA)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …summer internship is available in the CMC (chemistry, manufacturing and controls) Regulatory Affairs Department at the Foster City, CA, campus of Gilead ... an Undergraduate/Graduate Program with a focus in chemistry, biology, regulatory affairs or closely related subject. The...summer intern will provide support in the preparation of regulatory CMC submissions for investigational and marketed… more
- Bausch + Lomb (Sacramento, CA)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... preferred + Minimum of 8 years in recent experience in strategic pharmacuetical Regulatory Affairs . This position does not work with medical device, cosmetics… more
- Sumitomo Pharma (Sacramento, CA)
- …highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the ... Global Regulatory Affairs (GRA) team based in the US....the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of … more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …with 5+ years' experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, ... needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC -RA, labeling,...the global regulatory team (GRL, regional leads, CMC -RA, labeling, medical writing, regulatory operations, etc.)… more
- Sumitomo Pharma (Sacramento, CA)
- …a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs . The Associate Director is part of the Global ... Regulatory Affairs (GRA) team based in the...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
- Kelly Services (South San Francisco, CA)
- …& Clinical** is seeking a Vice President/ Senior Vice President, Global Regulatory Affairs for a direct-hire position at our late clinical-stage, ... in a high-growth environment-trust **The Experts at Hiring Experts.** **Title:** Vice President/ Senior Vice President, Global Regulatory Affairs **Pay:**… more
- AbbVie (Irvine, CA)
- …required by program needs, in partnership with Discovery, Translational, and CMC colleagues contribute to design and implement translational strategies. May ... opinion leader interactions related to the disease area(s); partners with Medical Affairs , Commercial and other functions in these activities as required, consistent… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to ... drug substance and drug product ensuring compliance with relevant ICH and regulatory guidelines + Develop and implement stability study protocols and timelines,… more
