- Bayer (Berkeley, CA)
- …etc.) + Knowledge/experience conducting risk assessments, authoring/reviewing documents for regulatory review , health authority and/or internal audit ... daily DR record management; + Maintain knowledge of current regulatory practices including a current understanding of USP/EP, cGMP...skills and ability to coach others in writing for regulatory audience + Strong analytical skills to identify root… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support. ... such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process + Review labeling content… more
- Abbott (Alameda, CA)
- …to achieve excellent compliance status with no enforcement actions. + Negotiate with regulatory authorities during the development and review process to ensure ... working mothers, female executives, and scientists. **The Opportunity** This **Associate Director Regulatory Affairs - APAC** will work on-site at our Alameda, CA,… more
- Edwards Lifesciences (Irvine, CA)
- …milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support. ... such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process + Review labeling content… more
- Abbott (Alameda, CA)
- …to achieve excellent compliance status with no enforcement actions. + Negotiate with regulatory authorities during the development and review process to ensure ... monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory … more
- Gilead Sciences, Inc. (Foster City, CA)
- …in scope, as teams are working earlier on TPPs and product strategies. . ** Regulatory Operations & Submissions** Oversee the drafting, review , and approval of ... Description** . **Strategic Leadership & Vision** Define and drive global regulatory strategies for combination products, ensuring alignment with corporate goals and… more
- Sumitomo Pharma (Sacramento, CA)
- …+ Coordinating and consulting with other departments on the content, review , and assembly of regulatory documentation. Ensure consistency, completeness, ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- Abbott (San Diego, CA)
- …applicable reports and responses to regulatory authorities. + Negotiate with regulatory authorities during the development and review process to ensure ... female executives, and scientists. **The Opportunity** This position, **Associate Director Regulatory Affairs** , works out of our **San Diego, CA** location… more
- BeOne Medicines (Emeryville, CA)
- …North America, Latin America, EEA, Middle East and Africa submission dossiers for regulatory Health Authority review and approval. This position will have ... **General** **Description:** This position resides in the Global Regulatory Operations Strategy & Innovation and will interact at all levels, including BeOne's… more
- AbbVie (Pleasanton, CA)
- …+ Ensure that technical information is accurate and in compliance with quality and regulatory requirements. + Review Design Changes post design transfer. + Work ... development process. + Support Design Verification and Validation activities, including review of verification & validation protocols and reports. + Assist in… more