- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... with a focus on gastrointestinal (GI) indications and a global regulatory remit. **Responsibilities:** + Provides high...a global strategy and can develop and lead execution of holistic regulatory strategy while… more
- AbbVie (South San Francisco, CA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… 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
- Medtronic (Santa Clara, CA)
- …(OU) is seeking a strategic and accomplished Sr. Director of Quality Assurance and Regulatory Affairs (QA/RA) to lead and evolve the global quality and ... MN. This position is on-site 4+ days/week. As **Sr. Director of Quality Assurance and Regulatory Affairs...Leadership & Organizational Development** + Lead a global team responsible for the Regulatory and… 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)
- …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
- 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)
- …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
- BeOne Medicines (San Mateo, CA)
- …leads and communicates CMC regulatory strategies for the assigned projects. + Lead regulatory risk assessment, identify key CMC regulatory issues and ... and process optimizations on relevant topics. **Essential Functions of the job:** + Lead , develop and implement small molecule CMC regulatory strategies as well… 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
- Medtronic (Santa Clara, CA)
- …more connected, compassionate world. **A Day in the Life** The Director of Global Marketing - Diagnostics will lead our global diagnostics portfolio, ... results. Reporting to the OU Global Marketing Director , this individual will lead a team...with other functional leaders (including business development, R&D, clinical, regulatory , sales and finance) to guide product innovation and… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Director , Comparator Sourcing, Global Clinical Supply Chain (GCSC) is ... GCSC has a strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. **Focus Areas:** + Oversees… more
- BeOne Medicines (San Mateo, CA)
- …resolution of GMP and GDP compliance matters. This role reports to the Senior Director , Global Clinical Operations Compliance Lead . **Essential Functions of ... **General Description:** The Director Global Clinical Supply Compliance builds,...as Quality Assurance, Supply Chain (commercial and/or clinical), Manufacturing, Regulatory Compliance, Clinical Development or a directly related area.… more
- Gilead Sciences, Inc. (Foster City, CA)
- …35 countries worldwide, with headquarters in Foster City, California. **Executive Director , Global Clinical Supply Chain (GCSC)** **KEY RESPONSIBILITIES:** ... Executive Director , Global Clinical Supply Chain is responsible for leading clinical...Has strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company. +… more