- 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:** 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)
- …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
- 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 Compliance builds, collaborates...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
- The Clorox Company (Pleasanton, CA)
- …**Your role at Clorox:** The Associate Director , Global Trade Compliance will ... lead the strategic direction and execution of world-class Global Trade Compliance programs across the enterprise. This role focuses on driving compliance… 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)
- 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)
- **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)
- … the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports ... is preferred. + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than 10%… more
- BeOne Medicines (Emeryville, CA)
- …CMC, Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge of global clinical trials and the drug development process. + Experience in vendor ... The Director of Comparator Purchasing, Clinical Supply Chain is...IRT system functionality and Excel modeling. + Understands comprehensive global pharmaceutical regulatory requirements (eg cGMP, ICH/GDP,… more
- Grifols Shared Services North America, Inc (Oakland, CA)
- …and evaluation for clinical trials; conduct site engagement calls and visits + Lead preparation of clinical sections of relevant regulatory filings (IND, study ... 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
- BeOne Medicines (Emeryville, CA)
- …and actively monitor vendor performance trends **Supervisory Responsibilities:** + Build & Lead global Digital Study Clinical Operations team of digital business ... **General Description:** The Director of Digital Clinical Operations Solutions Head is...the GCO digital strategy with the goal to increase Global Clinical Operations' productivity, reduce rising costs of clinical… more
- BeOne Medicines (Emeryville, CA)
- …success initiating change and influencing at all levels + Understands comprehensive global pharmaceutical regulatory requirements (eg GMP, GDP) + Strong ... **_General Description:_** Sr. Manager/Associate Director , Supply Chain CMO Management & PM will...work with functions within the company to support and/or lead new product introduction, new market launches as necessary.… more