- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... are met while leveraging expedited pathways where appropriate. The individual has regulatory affairs departmental and cross functional influence and acts as… more
- Gilead Sciences, Inc. (Foster City, CA)
- …live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory Affairs , you will develop and execute Oncology ... regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise...Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory… more
- AbbVie (South San Francisco, CA)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides ... assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other...current global and regional trends in biopharmaceutical regulatory affairs . Proven effectiveness applying this knowledge… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to fulfil their aspirations. Join Gilead and help create possible, together. **Job Description** Regulatory Affairs Global Labeling is a core function within ... Gilead's Global Regulatory Affairs organization and acts as a...contributes to special projects that advance the capabilities of Regulatory Affairs . + Trains other RA… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides ... assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other...or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help… more
- Ascendis Pharma (Palo Alto, CA)
- …Members, Product Management, and Leadership teams to develop and implement the US and global regulatory affairs plan across products + Oversee development ... programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve...area head for assigned products and lead the US RA Strategy team. This role involves managing regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic ... partner across cross-functional teams. Regulatory Affairs Labeling creates, updates, and maintains...State Linguistic Review and Closing Sequences. + Works with Global Labeling Leads (GLLs) and RA Liaisons… 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 across cross-functional teams. RA Ad/Promo provides strategic regulatory guidance and...Experience working with external contractors supporting the work of regulatory affairs is a plus. + Experience… more
- Abbott (Alameda, CA)
- …diversity, working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site ... 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… more
- Gilead Sciences, Inc. (Foster City, CA)
- …and inflammation, and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is ... scientific degree with directly relevant professional experience in biologics development, global CMC regulatory affairs , and CMC technical areas of at least… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Senior Director , Regulatory Affairs Strategy and Compliance is responsible for developing and implementing comprehensive ... regulatory strategies to ensure compliance with global ...trends and metrics across the development pipeline. The Senior Director will guide and support the timely review of… more
- Bristol Myers Squibb (Brisbane, CA)
- …more: careers.bms.com/working-with-us . **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of ... + Ensure global development plans will meet global regulatory requirements by soliciting and integrating...with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience… more
- BeOne Medicines (San Mateo, CA)
- …or/and medical device is a plus. * In-depth knowledge of ICH requirements, global regulatory CMC requirements; Knowledge/experience in Quality Assurance and GMP ... processes. The individual manages direct reports of 10+ and reports to global head of regulatory CMC. **Essential Functions of the job:** * Lead, develop, and… more
- BeOne Medicines (San Mateo, CA)
- …more Global Product Teams (GPTs). + Collaborate with R&D, Commercial, Medical Affairs , and Regulatory Affairs to ensure access-related insights and payer ... Description:** The position will report directly to the Executive Director (ED), Global Value, Access & Pricing...and communication. + Collaborate closely with Pricing, HEOR, Medical Affairs , Commercial, and Regulatory Affairs … more
- BeOne Medicines (San Mateo, CA)
- …while leveraging expedited pathways where appropriate. The individual will have regulatory affairs and cross-functional influence within the hematology ... **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Lead the Epclusa Established Products Team (EPT) + Partner with PDM, Trade Operations, Regulatory Affairs , and Medical Affairs to drive key initiatives, ... and improve life by advancing the care of patients with life-threatening diseases. ** Director , Global Commercial Product Strategy, Hepatitis C** Every member of… more
- Gilead Sciences, Inc. (Foster City, CA)
- …for health authority inspections. + Partners with other groups, including Regulatory Affairs , Clinical, Safety, Commercial, Supply Chain, Quality Control, ... Join Gilead and help create possible, together. **Job Description** **Executive Director , Global Head of Inspection** **Management** **Location:** Foster City,… more
- Abbott (Santa Clara, CA)
- …The individual will interact with multiple internal cross-functional teams, including R&D, medical affairs , regulatory affairs and finance to set the overall ... Abbott is a global healthcare leader that helps people live more...project management, clinical operations, clinical science, biostatistics, data management, regulatory affairs , medical affairs as… more
- Ascendis Pharma (Palo Alto, CA)
- …clinical research resource for-cross-functional colleagues (eg in clinical operations, statistics, regulatory affairs , medical affairs , health economics ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...employees to grow and develop their skills. The Medical Director is involved in the design, monitoring, data analysis,… more