- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director, Global Regulatory Lead , will be responsible for developing, implementing, and advising on global ... development, regulatory , and registration strategies. + The Director, Global Regulatory Lead supporting programs within BeOne's Hematology Franchise,… more
- Otsuka America Pharmaceutical Inc. (Sacramento, CA)
- …submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global ... submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains … more
- Merck (San Diego, CA)
- …submission experience in IBD strongly preferred. **Primary Responsibilities** + Develop and lead global regulatory strategies to support multiple ... & International Regulatory Affairs with prior experience as a Global Regulatory Lead + Demonstrated scientific knowledge, writing ability, effective… more
- Gilead Sciences, Inc. (Foster City, CA)
- …to align development and regulatory path for combination products and devices. . ** Global Regulatory Excellence** Lead the development of global CMC ... together. **Job Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with… more
- BeOne Medicines (Emeryville, CA)
- …and upgrades. + Perform impact analysis and prepare the organization to meet new global regulatory requirements. + Lead and participate in business process ... **General** **Description:** This position resides in the Global Regulatory Operations Strategy & Innovation...authoring standards, timelines, and tools. + Serve as APAC lead and SME for developing global electronic/paper… more
- Oura (San Francisco, CA)
- …compliance program, ensuring alignment with global best practices and regulatory expectations. + Lead anti-bribery and anti-corruption (ABAC) compliance, ... regulatory compliance with commercial objectives. What you will do: FDA & Global Regulatory Compliance: + Serve as the primary legal advisor on FDA, EU MDR,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … strategies and tactical plans for submissions regulatory bodies + Liaises with global RA lead (s), to ensure strategic alignment as needed + Identifies and ... + Actively contribute to key strategic decisions impacting the development of global regulatory compliance policies, processes, and procedures + Establishes… more
- Gilead Sciences, Inc. (Foster City, CA)
- …assigned molecules /products considering both strategic and technical aspects + Contribute to global regulatory filing strategy and lead clinical development ... area with phase 3 and 4 PBC studies and global regulatory filings underway or expected, with...skillset as needed to meet team goals; ability to lead both strategic work as well as having high… more
- Abbott (Alameda, CA)
- …Opportunity** Lingo is seeking an impactful Global Head of Quality and Regulatory Affairs to lead our innovative biowearables initiative and drive the next ... environment. + Regulatory Strategy: Develop and execute global regulatory strategies and roadmaps for product...submissions and clearances across diverse markets. + Market Expansion: Lead regulatory activities for launching Lingo in… 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