- 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 (Emeryville, 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
- 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)
- **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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …regulations and current environment to assure approvability in high priority regions. As a regulatory lead you will also be responsible for ensuring that ... and help create possible, together. **Job Description** The Associate Director , CMC Regulatory Affairs for Biologics is...global regulatory strategy is integrated into Pharmaceutical… 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
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - US New Product Introduction and ... regulatory metrics/information. **WHAT YOU'LL DO** + Develop global regulatory strategies for product development and...unit assigned. + Create project plans and timelines. + Lead functional groups in the development of relevant data… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner ... process improvements or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance on new marketing… more
- Stryker (Fremont, CA)
- …benefits. (https://d25zu39ynyitwy.cloudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) The ** Director , Global ... generation, scientific writing, physician engagement and medical safety within the global NV business. More specifically, responsible for creating and maintaining… more
- ThermoFisher Scientific (South San Francisco, CA)
- …**Environmental Conditions** Office **Job Description** Job Description The Director of Global Market Development for qPCR will lead a team of marketing ... academic labs, Pharma/Biotech, service providers, reference labs, hospitals), competitive environment, regulatory landscape and global market trends globally. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …than 35 countries worldwide, with headquarters in Foster City, California. **Executive Director , Global Clinical Supply Chain (GCSC) - Virology** **KEY ... RESPONSIBILITIES:** Executive Director , Global Clinical Supply Chain is responsible...Has strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. +… more
- BeiGene (Emeryville, CA)
- …to the VP of Global Business Operations, the Senior Director , Global Congresses and Meetings will lead a team of congress and events professionals ... team. The role provides an opportunity to shape and lead the BeiGene Global Congress and Meetings...a compliant manner with BeiGene policies, procedures, and local regulatory /legal requirements, company policies and code of conduct. +… more
- Pfizer (San Francisco, CA)
- **ROLE SUMMARY** The Medical Digital Health Lead , Sr. Director plays a pivotal role in closing care gaps through Medical digital innovation. This individual ... works within Global Medical Affairs with the goal to manage the...digital health initiatives from ideation to lifecycle management. + Lead a matrix of SMEs from different therapeutic areas… more
- BeiGene (Emeryville, CA)
- …and takes a lead role in vendor governance + Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency ... and execution of clinical operations' deliverables at the regional level + Lead therapeutic area/s (TA) within Clinical Operations with responsibility for line… more
- Bristol Myers Squibb (Brisbane, CA)
- …their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Science Lead reports through the Clinical Science function which provides scientific ... assigned area + May serve as a Clinical Trial Lead or Co- Lead as needed + May...to clinical study reports (CSRs) and clinical portions of Regulatory Documents (eg, IB, DSUR, regulatory responses)… more
- BeiGene (Emeryville, CA)
- …Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update ... experience, including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance. **Travel:** Less than 10%… more
- BeiGene (Emeryville, CA)
- **General Description:** The Risk Based Quality Management Lead will create risk assessments for any entity in clinical development, follow up on quality signals, ... agreed results against a plan and timeline + Understanding of ICH and regulatory environment + Problem-solving skills + Self-management skills + Ability to work in… more