- BeiGene (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)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory Strategy, is ... 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)
- …level as a global lead that ensures "right first time" global approvals of CMC regulatory (Biologics) submissions, and "right to operate" by maintaining ... in Foster City, California. **About the Role:** The Senior Director , CMC Regulatory Affairs for Biologics is...Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation… more
- BeiGene (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
- Ascendis Pharma (Palo Alto, CA)
- …US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy . ... The Regulatory Affairs (RA) Associate Director , Labeling...for the United States and the Americas and supporting global needs as required. The RA Associate Director… more
- Gilead Sciences, Inc. (Foster City, CA)
- … Advertising and Promotion (RA Ad/Promo) is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner ... process improvements or other special projects. May initiate and/or contribute to global process improvements. + Provides regulatory guidance on new marketing… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Global Commercial Strategic Marketing, Virology & Established Products, the **Executive Director , HIV Global Strategic Marketing** is responsible for the ... to frame and solve key business problems and build effective marketing plans. + Lead materials development to support Earnings Calls, Global LE Guidance, and… more
- Abbott (Santa Clara, CA)
- …in Sylmar, CA or Santa Clara, CA currently has an on-site opportunity for a ** Global Clinical Project Director ** . This new team member is a leader within ... Abbott is a global healthcare leader that helps people live more...for the Neuromodulation business. In this role, you will lead high-performing cross-functional teams to ensure speed and innovation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Create and oversee data metrics to evaluate and enhance digital offerings + Lead global digital innovation process, projects and partnerships by identifying ... patient centric, science focused company. Reporting to the Executive Director of Global Medical Affairs, Insights, Digital...advise in cross functional governance, standards and SOPs for global MA digital assets and capabilities + Lead… more
- BeiGene (San Mateo, 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 (San Mateo, CA)
- …of escalation for resolution of issues of the associated program(s) in the Franchise(s) + Lead and manage the Global Clinical Program Lead (GCPL)/ Global ... **General Description:** + Leveraging deep Therapeutic Area/Asset expertise, solid global program management skills, global view, and borderless leadership, the… more
- Pfizer (South San Francisco, CA)
- … regulatory requirements of different sites and countries. + Ability to lead cross-line global initiatives or root cause analysis for quality related ... within the Pfizer Oncology clinical portfolio. + With this focus, the Asset Quality Lead (AQL) role brings deep knowledge of Level One quality issues and risk areas… more
- Gilead Sciences, Inc. (Foster City, CA)
- …together. **Job Description** **Essential Duties and Job Functions** + Serves as the global Medical Affairs Digital strategy lead developing and implementing the ... digital tools + Works in close alignment and collaboration with HIV counterparts from Global Strategic Marketing, Global Public Affairs and Global legal to… more
- Gilead Sciences, Inc. (Foster City, CA)
- …we strive to cure unmet medical needs? R&D Quality is seeking a Senior Director , Inflammation TA Lead to join our Clinical Quality Business Partners Leadership ... Team. In this role you will lead and set strategy for a global ...with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory Operations and Clinical Data Sciences. + Collaborate with… more
- BeiGene (San Mateo, 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
- JPMorgan Chase (Palo Alto, CA)
- …the opportunity to take your career to the next level. As a Market Team Lead in the US Private Bank, you are responsible for advising families on building, ... approach while strictly adhering to all risk and control policies, regulatory guidelines and security measures **Required Qualifications, Capabilities, and Skills**… more
- BeiGene (San Mateo, 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 (San Mateo, CA)
- … the analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports ... Qualifications:** + Pharmaceutical product development experience + Experienced in global regulatory requirements for pharmacovigilance **Travel:** Less than… more
- Ascendis Pharma (Palo Alto, CA)
- …needed. + Under the direction of Head of Global Medical Safety Science, lead responses to ad-hoc safety queries from Regulatory Authorities in a timely ... to grow and develop their skills. Medical Safety Science Director reports to Head of Global Medical...FDA, EMA PV regulations, ICH Guidelines, and other applicable regulatory guidance documents; working knowledge of global … more
- Stanford University (Stanford, CA)
- …on the school, clickhere. The SDSS Sustainability Accelerator seeks a full-time Managing Director to lead Flagship Destination programs in the areas of Food ... Director Yi Cui and Executive Director Charlotte Pera, the Managing Director will lead the development and implementation of the Flagship Destination's… more