- BeiGene (Emeryville, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... on Health Authority interactions. + Uses extensive knowledge of global regulatory requirements and the ability to...a global strategy and can develop and lead execution of holistic regulatory strategy while… more
- BeiGene (San Mateo, CA)
- The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory ... Functions of the job:** + Uses extensive knowledge of global regulatory environment and the ability to...+ Preferred candidates will have experience working as a lead in Regulatory Affairs across two or… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, is ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- AbbVie (Irvine, CA)
- …pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, is ... + Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy… more
- Takeda Pharmaceuticals (Sacramento, CA)
- …pertaining to global and local labeling compliance and quality within Global Regulatory Affairs. + Partners with internal stakeholders and external CRO ... to the best of my knowledge. **Job Description** The Regulatory Affairs-Labeling, Associate Director is responsible for...partners such as Global Regulatory Compliance, Global Labeling,… more
- Takeda Pharmaceuticals (Sacramento, CA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- BeiGene (Emeryville, CA)
- …of department policies. **Key Responsibilities:** Regulatory Strategy Development: + Lead the global regulatory strategy for companion diagnostics, ... The Executive Director of Regulatory Affairs, Companion Diagnostics...will be responsible for developing, advising on and executing global regulatory strategies for companion diagnostic products… more
- BeiGene (Emeryville, CA)
- …Description:** The incumbent will: + Lead the activities of the Global Regulatory Affairs SOP Committee regarding life-cycle management of Global ... the Document Change Process + Guide external personnel to Global Regulatory Affairs to comply with SOP...biotechnology industry, with 5+ years of experience as a Regulatory Affairs compliance lead . **Other Qualifications:** +… more
- BeiGene (San Mateo, CA)
- **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible for managing a team of NA leaders within the Hematology ... coordination with key internal stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of at least 2 strategist) who… more
- Gilead Sciences, Inc. (Foster City, CA)
- …ways of working within the organization. This role ensures compliance with global regulatory data requirements, drives data quality initiatives, and facilitates ... help create possible, together. **Job Description** The Data Governance Lead for Regulatory Affairs will be responsible...alignment between global regulatory affairs and cross-functional teams. The… more
- Takeda Pharmaceuticals (Sacramento, CA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Global Foundries (Santa Clara, CA)
- …to shape their markets. For more information, visit www.gf.com . Job Summary: The Director of Global Benefits and Mobility is responsible for the strategic ... aligned with the company's overall business objectives . The Director will work closely with HR leaders, finance, legal,...years in a leadership capacity. + Deep understanding of global benefits trends, mobility practices, and regulatory … more
- Sumitomo Pharma (Sacramento, CA)
- …experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based ... the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory... Lead , manage regional (United States and/or European) regulatory activities as part of a Global … more
- Sumitomo Pharma (Sacramento, CA)
- …, Regulatory Affairs** . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as ... registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected... Lead , manage regional (United States and/or European) regulatory activities as part of a Global … more
- AbbVie (Irvine, CA)
- …affairs function regulatory requirements. Proactively monitor and interpret the external global regulatory environment for regulatory issues, trends, and ... in which AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements. Director , Safety, Regulatory and Medical… more
- Merck (Sacramento, CA)
- … CMC Oversight + Lead the preparation and submission of high-quality regulatory CMC device content for global submissions, including IND, NDA, BLA, and ... **Job Description** The Executive Director , Device Quality & Regulatory will... regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and… more
- AbbVie (South San Francisco, CA)
- …Director to join our growing regulatory team. In this role you would be the Global Regulatory Lead where you will develop and implement global ... currently seeking a Regulatory Affairs ...Francisco, CA location. Key Responsibilities: + Serve as the Global Regulatory Lead on project...Key Responsibilities: + Serve as the Global Regulatory Lead on project teams and key… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our ... Abbott is a global healthcare leader that helps people live more...Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is… more
- Charles River Laboratories (Northridge, CA)
- …at Cell Solutions, you will make a difference every day. **Job Summary** The Director , Regulatory Affairs and Quality Assurance is responsible for ensuring the ... of hosting or leading regulatory inspections and preparing staff for regulatory inspections * Strong working knowledge of global GMP/GLP requirements,… more
- Bristol Myers Squibb (San Diego, CA)
- …the regulatory landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for ... more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of… more