- BeOne Medicines (Emeryville, 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
- BeOne Medicines (Emeryville, 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
- BeOne Medicines (Emeryville, 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
- BeOne Medicines (Emeryville, 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 (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
- BeOne Medicines (Emeryville, 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
- 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 (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 ... **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 (Emeryville, 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
- BeOne Medicines (Emeryville, CA)
- The Global Executive Medical Science Director (ex-China) for Hematology GMA will report directly to the Vice President, Hematology Lead for GMA. Under the ... responsible for developing and implementing all aspects of the global medical strategy for BeOne Hematology assets. The primary...BeOne Hematology assets. The primary focus will be to lead and ensure execution of all programs and functions… more
- Abbott (Alameda, CA)
- …**The Opportunity** We are seeking a Director of HCP Marketing to lead global strategy and execution for healthcare professional (HCP) engagement across the ... **What You'll Work On** This role sits within the Global Strategic Marketing (GSM) team and will lead...Work closely with Medical Affairs, Clinical, Market Access, Legal, Regulatory , and Area Marketing teams to ensure scientific rigor,… more
- BeOne Medicines (Emeryville, CA)
- …implementing, and maintaining QMS processes in alignment with organizational goals, regulatory requirements, and industry standards. The Director , QMS Process ... **General Description:** The Director , QMS Process Owner is responsible for overseeing...Global Change Control process to ensure compliance with regulatory , customer, and organizational requirements. + Act as the… more
- BeOne Medicines (Emeryville, CA)
- …including individual study design and filing plans. + Experienced in global regulatory requirements for pharmacovigilance + Appropriate experience with ... The Senior Medical Director serves as the Lead Product...response plan, reviews ongoing issue and plan + Reviews regulatory inquiry to lead strategizing the nature… more
- Meta (Fremont, CA)
- …Europe, Middle East and Africa and Asia. **Required Skills:** Director , Global Storage and Distribution Responsibilities: 1. Lead , develop, and grow ... **Summary:** The Director of Global Storage and Distribution...needs of supply chain and manufacturing at hyperscale. 5. Lead the pilot and mass production launch of custom… more
- BeOne Medicines (Emeryville, CA)
- The Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often ... response plan, reviews ongoing issue and plan + Reviews regulatory inquiry to lead strategizing the nature...the program / portfolio being led. The Executive Medical Director serves as Product Safety Physician Lead … more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Digital Clinical Operations Solutions Lead is responsible to formulate and implement GCO digital strategies with ... the goal to increase Global Clinical Operations' productivity and reduce clinical trial inefficiencies....are cohesive, efficient, reliable, and compliant with all applicable regulatory expectations. + Implement the GCO technology roadmap to… more
- BeOne Medicines (Emeryville, CA)
- …for the resolution of issues on the studies within responsible program(s). + Lead the Global Clinical Study Managers (gCSMs) in designated programs while ... **General Description:** + Leveraging deep Therapeutic Area expertise, solid global program management skills, global view, and borderless leadership, the GCPL… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** BeOne's Global Technology Solutions team is seeking an experienced and strategic technical leader to serve as both the ITSM Lead and ... technology-enabled transformation across the organization by aligning enterprise, regional, global , and functional requirements into a cohesive platform strategy.… more
- BeOne Medicines (Emeryville, 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
- BeOne Medicines (Emeryville, CA)
- …integration across functional areas. + Ensure that all QMS processes comply with applicable global regulatory requirements (eg, FDA, EMA, ISO 9001, ICH Q10). + ... Process Owners, driving organizational alignment, and ensuring that QMS processes meet regulatory requirements and business needs. The Senior Director plays a… more