- 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)
- …strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and love ... a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will be responsible for… more
- BeOne Medicines (San Mateo, CA)
- …role provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs , Quality, Safety/Pharmacovigilance, Clinical, CMC , and ... **General Description** **:** The Manager, Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for… 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
- Parexel (Sacramento, CA)
- …strategic thinker with a passion for navigating the complex world of global regulatory affairs ? Do you thrive in cross-functional environments and love ... a dynamic and experienced Post-Approval Regulatory Strategy Lead to join our Regulatory Affairs team. In this pivotal role, you will be responsible for… 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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs , Clinical Development and Technical ... deliverables. + Serve as an author and reviewer of CMC sections in regulatory filings, and support...products and problems. + Works in collaboration with more senior scientists or scientific directors to advance the development… 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
- AbbVie (Irvine, CA)
- …brands (Development, Discovery, Development Sciences, Operations, Commercial, Market Access, Regulatory , Safety, Project Management, Medical Affairs , etc., and ... project's primary point of contact for Pipeline Governance and senior management. + Has a broad vision for the...cross-functional teams (eg, Global Commercial Team, Global Brand Team, CMC , Integrated evidence strategy team, Value and Access team,… more
