- BeiGene (San Mateo, 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
- Gilead Sciences, Inc. (Foster City, CA)
- …level as a global lead that ensures "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining ... in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is...Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation… 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
- Ascendis Pharma (Palo Alto, CA)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... The Regulatory Affairs (RA) Associate Director , Labeling...for the United States and the Americas and supporting global needs as required. The RA Associate Director… 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
- Bausch Health (San Francisco, CA)
- …and related submission work. + Partner with other regions to support product global regulatory expansion. + Work in collaboration with Bausch Health Group ... Promotional Review Committee Regulatory lead , ensuring regulatory compliance...510(K), Health Canada, EU MDD/MDR Technical Documentations, STEDs for global registration purposes as appropriate, related submission work. +… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Global Commercial Strategic Marketing, Virology & Established Products, the **Executive Director , HIV Global Strategic Marketing** is responsible for the ... to frame and solve key business problems and build effective marketing plans. + Lead materials development to support Earnings Calls, Global LE Guidance, and… more
- BeiGene (San Mateo, CA)
- …cancer and our commitment to serve patients wherever they reside. As the Senior Director , Global Commercial Leader, Breast Cancer Disease Area Strategy (DAS) and ... process, and a keen business acumen. The role reports to the Vice President, Global Commercial Solid Tumor Franchise Lead . **Essential Functions:** + Create and… more
- Pfizer (South San Francisco, CA)
- …team at global industry events, conferences and symposia. The Sr. Director , Internal Medicine Migraine Scientific Lead is a seasoned individual contributor ... markets into one team to drive efficiency through internalized work. The Sr. Director , Internal Medicine Migraine RWE Scientific Lead plays a critical role… more
- WTW (San Francisco, CA)
- This Senior Director role in WTW's Integrated & Global Solutions business is an exciting mix of sales and delivery focused on helping global organizations ... You will be responsible for selling and leading projects associated with the global management of insured benefits (including global benefit financing), the … more
- Gilead Sciences, Inc. (Foster City, CA)
- …Create and oversee data metrics to evaluate and enhance digital offerings + Lead global digital innovation process, projects and partnerships by identifying ... patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs, Insights, Digital...advise in cross functional governance, standards and SOPs for global MA digital assets and capabilities + Lead… more
- BeiGene (San Mateo, CA)
- …of escalation for resolution of issues of the associated program(s) in the Franchise(s) + Lead and manage the Global Clinical Program Lead (GCPL)/ Global ... **General Description:** + Leveraging deep Therapeutic Area/Asset expertise, solid global program management skills, global view, and borderless leadership, the… more
- Pfizer (South San Francisco, CA)
- … regulatory requirements of different sites and countries. + Ability to lead cross-line global initiatives or root cause analysis for quality related ... within the Pfizer Oncology clinical portfolio. + With this focus, the Asset Quality Lead (AQL) role brings deep knowledge of Level One quality issues and risk areas… more
- Gilead Sciences, Inc. (Foster City, CA)
- …we strive to cure unmet medical needs? R&D Quality is seeking a Senior Director , Inflammation TA Lead to join our Clinical Quality Business Partners Leadership ... Team. In this role you will lead and set strategy for a global ...with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory Operations and Clinical Data Sciences. + Collaborate with… 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 (San Mateo, 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 (San Mateo, 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
- BeiGene (San Mateo, CA)
- … the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports ... Qualifications:** + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than… more