- Lilly (San Francisco, CA)
- …to make life better for people around the world. **Purpose:** The purpose of the Senior Director , Global Regulatory Affairs , Global Regulatory ... leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers. + Participate in forums that share… more
- BeOne Medicines (Emeryville, 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)
- …Description** Regulatory Affairs Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic ... contributes to special projects that advance the capabilities of Regulatory Affairs . + Trains other RA...of current global and regional trends in regulatory affairs and is able to apply… 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
- 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 (Emeryville, 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 (Emeryville, 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 (Emeryville, 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 (Emeryville, 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
- AbbVie (San Francisco, CA)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager, RA Global Regulatory Strategy, US & Canada position is ... with multiple driver indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director , or Director… more
- Abbott (Alameda, CA)
- …medical event reporting policies, procedures and processes are in place to meet global regulatory requirements. Provide metrics on medical events to support ... capture and document all potential reportable events to meet global regulatory requirements. + Ensures that CFR...years of experience in Quality Systems, Quality Assurance and/or Regulatory Affairs + Medical device industry or… more
- Grifols Shared Services North America, Inc (San Francisco, CA)
- …regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve as program medical expert ... the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working...than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating to… more
- Surrozen (South San Francisco, CA)
- …with multidisciplinary teams including preclinical development, biostatistics, clinical operations, quality, regulatory affairs and CMC. As leader of the ... AMD/uveitic macular edema (UME). Reporting directly to the CEO, the Exec. Director /VP Clinical Development will contribute to and lead early clinical programs in… more