- Merck (San Diego, CA)
- **Job Description** The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the ... point of contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling. This… more
- United Therapeutics (Sacramento, CA)
- … affairs or a related area of study or 7+ years of biologic or pharma regulatory experience with a PhD in life sciences, quality, regulatory affairs or ... hearts. **Who you are** We are looking for a regulatory strategist who will advise on regulatory ...a regulatory strategist who will advise on regulatory pathways, managing documentation and timelines, and supporting the… more
- Abbott (San Diego, CA)
- …female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego, CA** location ... (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs. We're empowering smarter medical and economic decision-making to help transform… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and conduct of clinical studies from early through late stage development and regulatory interactions. + PhD degree in Biostatistics or equivalent and minimum ... (TA), and oversee all biostatistics workstreams for clinical trials, assets evaluations, and regulatory submissions in the TA. The ideal candidate will have a proven… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …and/or review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to upstream processing. + ... Collaborate closely with Downstream MSAT, Validation MSAT, QA, Regulatory , Process Development, and CDMO technical teams. + Stay current with advancements in… more
- The Brattle Group (San Francisco, CA)
- …are completing their PhDs by the summer of 2026) as well as experienced PhD 's who have been in the workplace (consulting, government, academia, industry, or other ... enough to be sought after to answer complex economic, regulatory , and financial questions for clients around the world....Principals and testifying experts. **Ideal Candidates Will Possess** + PhD in Economics or related field with a strong… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. + ... Collaborate closely with Upstream MSAT, Validation MSAT, QA, Regulatory , Process Development, Analytical Development, and CDMO technical teams. + Stay current with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Labeling is a core function within Gilead's Global ... Regulatory Affairs organization and acts as a critical strategic...seek for this role. **Preferred Education & Experience** + PharmD/ PhD with 2+ years' relevant experience. + MA/MS/MBA with… more
- Gilead Sciences, Inc. (Foster City, CA)
- …respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director, CMC Regulatory Affairs for Biologics is responsible for defining regulatory ... will ensure "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining...with a BA/BS or 10 years with an MA/MS, PhD , PharmD, or MD. + Demonstrated track record in… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …position is responsible for support of a variety of international related regulatory activities continuous improvement and regulatory projects. This position is ... to international geographies, providing guidance and advice on international regulatory requirements, providing oversight to and preparation of worldwide submissions… more