- Gilead Sciences, Inc. (Foster City, CA)
- …years' relevant experience. + BA/BS with 10+ years' relevant experience. + Significant regulatory , quality , compliance or related experience in the biopharma ... will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA...required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets. + Ensures… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …contribute to key strategic decisions impacting the development of global regulatory compliance policies, processes, and procedures + Establishes organization ... a **maker of possible** with us. The Sr. Director, Regulatory Affairs is the ranking Regulatory Affairs...+ Current and comprehensive knowledge of global regulations and quality systems are required + Strong project … more
- Abbott (Alameda, CA)
- …labeling. + Acts as core team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed. + ... help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with...promotional materials while working with Marketing teams to provide regulatory strategy and compliance input. + Assist… more
- GRAIL (Menlo Park, CA)
- … Quality , Lab Operations, and other stakeholders to support regulatory strategy development, product validation, audits, promotional material review, on-market ... products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor and report on… more
- Terumo Neuro (Aliso Viejo, CA)
- …teams, at times act as sole representative from Regulatory to ensure regulatory compliance . + Depending on product/ project complexity, develop or assist ... strategy/submissions per MicroVention procedures. + Review promotional material and labeling for regulatory compliance as assigned. + Perform and/or oversee the… more
- Abbott (Alameda, CA)
- …issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. + Create project plans and timelines. + ... regulatory submission. + Write and edit technical documents. + Administer/meet regulatory requirements to achieve excellent compliance status with no… more
- Chemours (Sacramento, CA)
- …Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw material components and/or 5+ ... teams including product development, business initiatives and market assessments ensuring regulatory and voluntary standard integration and compliance in… more
- Abbott (Alameda, CA)
- … affairs and compliance to establish a compliant culture. + Represent Regulatory Affairs on cross-functional project teams and provide strategic input and ... approval requirements + Review product labeling and promotional materials to ensure compliance with relevant regulatory requirements. + Provide regulatory … more
- Abbott (Santa Clara, CA)
- …a mentor to less-experienced staff + May lead a cross-functional or cross-divisional project team + Responsible for compliance with applicable Corporate and ... and review process to ensure submission approval + Ensure compliance with US and global product post marketing approval...(eg, medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance,… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide ... and guidance; assess impact of such regulations and guidance on assigned project (s), propose suggestions on utilizing regulatory updates to expedite approval… more