- BeiGene (Emeryville, 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
- BeiGene (Emeryville, CA)
- The Executive Director , Global Regulatory Portfolio Lead will be responsible for developing, implementing, and advising on global regulatory ... Functions of the job:** + Uses extensive knowledge of global regulatory environment and the ability to...+ Preferred candidates will have experience working as a lead in Regulatory Affairs across two or… more
- BeiGene (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
- BeiGene (Emeryville, CA)
- …drive process improvements, enhance supply planning capabilities, and ensure compliance with global regulatory requirements. Success in this role requires strong ... **General Description:** The Associate Director of Commercial Supply Planning plays a critical...the S&OP process to drive business alignment. + **Pharmaceutical Regulatory Knowledge:** Comprehensive understanding of global pharmaceutical… more
- BeiGene (Emeryville, CA)
- …working successfully within diverse matrix teams. The role reports to the Executive Director , Global Commercial Lead , TEVIMBRA. **Essential Functions of the ... to serve patients wherever they reside. As the Associate Director , Global Marketing, TEVIMBRA, you will play...strategies support organizational goals. Under the direction of the Global Brand Lead , and in partnership with… more
- BeiGene (Emeryville, CA)
- …to the VP of Global Business Operations, the Senior Director , Global Congresses and Meetings will lead a team of congress and events professionals ... team. The role provides an opportunity to shape and lead the BeiGene Global Congress and Meetings...a compliant manner with BeiGene policies, procedures, and local regulatory /legal requirements, company policies and code of conduct. +… more
- BeiGene (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
- BeiGene (Emeryville, CA)
- …& non-interventional). + Experience managing a CRO, understanding of global regulatory requirements for company-sponsored trials. + Detail-oriented, ... **General Description:** + Work with country or global teams to plan and implement Phase IV...+ Work with the responsible party (eg Country Medical Director , HEOR lead ) to create the implementation… more
- BeiGene (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
- BeiGene (Emeryville, CA)
- **General Description:** The Risk Based Quality Management Lead will create risk assessments for any entity in clinical development, follow up on quality signals, ... agreed results against a plan and timeline + Understanding of ICH and regulatory environment + Problem-solving skills + Self-management skills + Ability to work in… more
- BeiGene (Emeryville, CA)
- …improvement initiatives with cross functionally with stakeholders contributing to global /regional initiatives or programs. + Lead monthly Supply ... **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply...Regulatory , etc.) stakeholders. + Demonstrates advanced knowledge of global clinical trials and the drug development process. +… more
- BeiGene (Emeryville, CA)
- …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
- BeiGene (Emeryville, CA)
- …Americas, Clinical Operations, the Director - Clinical Trial Diversity, will lead BeiGene's goals to increase global clinical trial diversity across ... This role will work actively and directly with the Clinical Operations, Regulatory , Clinical Development, and Human Resources to support their efforts to advance… more
- BeiGene (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
- BeiGene (Emeryville, CA)
- …role ensures effective communication and governance for QMS-related projects and initiatives at a global level. + Lead the development and execution of the QMS ... **General Description:** The Director , QMS Project and Portfolio Management, is responsible...System (QMS) portfolio, ensuring alignment with organizational priorities and regulatory requirements. This role involves developing and managing the… more
- BeiGene (Emeryville, CA)
- …partners and internal stakeholders **Desired Qualifications:** + Strong understanding of global manufacturing processes, supply chain management, and regulatory ... **General Description:** The Executive Director for Manufacturing Operations Business Development will be responsible for identifying, evaluating, and developing new… more
- BeiGene (Emeryville, CA)
- …performance trends **Supervisory Responsibilities:** + Be an individual contributor + Build & Lead global Digital Operations Data Analyst(s) team (as needed) + ... **General Description:** The Director of Digital Clinical Operations Data Products Head...global biotech company + **Leadership** : Ability to lead and mentor a team of data professionals, providing… more
- BeiGene (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...of the job:** + Develop, implement, and maintain the Global Deviations, Product Quality Complaints, CAPA processes to ensure… more
- Barry Callebaut (American Canyon, CA)
- Director , Sales, FM West Location: American Canyon, US, 94503 At Barry Callebaut, we are on a journey to transform the cocoa and chocolate industry. As the world's ... and beyond! About the role: Barry Callebaut is a global organization poised for growth; a company that has...living BC's Values, and of course, loving chocolate. The Director , Sales, FM West is a strategic leadership role… more
- AIG (San Francisco, CA)
- Claims Complex Director - Healthcare Professional Liability (HPL) Join us as a Claims Complex Director to take on key responsibilities within a world-class ... excellence and showcasing our service differentiation to create an unparalleled global claims handling experience. Through a robust stakeholder feedback loop and… more