- BeOne Medicines (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
- AbbVie (South San Francisco, CA)
- …Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Lilly (San Francisco, CA)
- …The purpose of the Senior Director , Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative ... drive acceleration strategies. Identify and effectively communicate regulatory risks. + Lead Global Regulatory Team in the development of regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …the role is primarily focused on early oncology assets, you may act as the Global Regulatory Lead for early-stage, late-stage, or other programs depending on ... live or their economic status. **POSITION OVERVIEW:** As a Director , Early Oncology Global Regulatory ...and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Regulatory Affairs Global Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner ... will serve as a central contact and expert for global Regulatory teams in interpreting content and...advisor to cross-functional partners, stakeholders, and teams. You will lead impact assessments on major global labeling… more
- Gilead Sciences, Inc. (Foster City, CA)
- … strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… more
- Gilead Sciences, Inc. (Foster City, CA)
- … strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will ... Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides… 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 ... ability to rapidly learn new therapeutic areas. + Demonstrates in-depth knowledge of current global and regional trends in regulatory affairs and is able to… more
- BeOne Medicines (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)
- …products. + Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right ... and serious respiratory and cardiovascular conditions. **KEY RESPONSIBILITIES** The Director , CMC Regulatory Affairs for Biologics is...submissions. + Lead the execution of these global CMC regulatory plans, including overseeing the… more
- BeOne Medicines (San Mateo, CA)
- **General Description:** The Global Strategic Feasibility Lead leads the development of Global Strategic Feasibility proposals together with the regional ... development across global clinical operations (GCO). Good understanding of global , regional, and country landscape and regulatory requirements. Drive… more
- Ascendis Pharma (Palo Alto, CA)
- …Product Management, and Leadership teams to develop and implement the US and global regulatory affairs plan across products + Oversee development and refinement ... Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe,...programs in Endocrinology Rare Disease and Oncology. The Sr. Director , Regulatory Affairs will serve as the… 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
- BeOne Medicines (San Mateo, CA)
- …Description:** The position will report directly to the Executive Director (ED), Global Value, Access & Pricing (GVAP) Lead , Hematology, and will be ... no Company Leadership endorsement for making the first major regulatory filing has occurred. Under the above definition, an...of the job:** **Pipeline Market Access Strategy Development:** + Lead the creation and implementation of global … more
- BeOne Medicines (San Mateo, CA)
- …Description:** This position will be responsible for the delivery of high-quality global medical information in support of BeOne hematology products. This role ... encompasses global product specialist responsibilities for the Hematology franchise, contributions...additional product-specific core teams and initiatives. + Apply legal, regulatory , and compliance requirements to all Medical Affairs activities.… 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
- 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 ... **General Description:** BeiGene is seeking an experienced and instrumental regulatory professional to lead US biologics ...individual manages direct reports of 10+ and reports to global head of regulatory CMC. **Essential Functions… more
- Bristol Myers Squibb (Brisbane, 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
- Gilead Sciences, Inc. (Foster City, CA)
- …more than 35 countries worldwide, with headquarters in Foster City, California. **Senior Director , Global Clinical Supply Chain** Senior Director , Global ... that provides relevant expertise in a fast-paced biopharmaceutical environment. The Senior Director works internally with other members of Global Supply Chain… more
- BeOne Medicines (San Mateo, CA)
- …location in United States and on the East Coast **General Description:** The Global Director of Pricing holds responsibility for developing and executing ... are optimized for payer clinical assessments. Within the assigned geographic scope, the Global Director of Pricing manages price bands and oversees gross-to-net… more