Senior Manager Regulatory Affairs

Regulatory Affairs Vendor Governance is a function within the RA Business Operations group supporting all of Gilead RAs subfunctions. Vendor Governance is responsible for the selection, implementation, governance, relationship management, tracking, Regulatory Affairs, Vendor, Manager, Regulatory, Business Operations, Senior, Business Services

Location: San Jose, CA About: Currently working with a medical device company dedicated to developing and commercializing breakthrough catheter devices that revolutionize patient care on a Regulatory Head position. In this critical role, you will play a pivotal role in ensuring our breakthrough catheter devices navigate the regulatory pathway efficiently...

The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system. Duties & Responsibilities: Review and approve audit agenda, plan, summary reports for internal audits. Facilitate and participate in external audits and collaborate with Quality Assurance...

Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...

Company Location: Bay Area Comp: 150K-220K Position Reports to: VP of Regulatory and Quality Director of Regulatory Affairs -San Francisco We are seeking a highly motivated and experienced Senior Director of Regulatory Affairs for a Medical Device Orthopedic Portfolio. This person will lead interactions with regulatory agencies globally and help develop &...

Job Title  Regulatory Affairs Analyst  | Requisition ID req607  Type of Employment Regular Full-Time Employee | Job Openings 1 Compensation Range - style="text-align:left;"> | Compensation Type Annual Salary Founded in 1866, San Jose Water Company is an investor owned water company headquartered in Silicon Valley. With a service...

Job Title  Regulatory Affairs Analyst  | Requisition ID req607  Type of Employment Regular Full-Time Employee | Job Openings 1 Compensation Range - style="text-align:left;"> | Compensation Type Annual Salary Founded in 1866, San Jose Water Company is an investor owned water company headquartered in Silicon Valley. With a service...

Job SummaryThe Living Therapeutics Initiative seeks a highly motivated Regulatory Affairs Senior Manager to manage the regulatory affairs, author and assemble IND applications, and help manage FIH studies advancing UCSF-developed cellular therapy candidates. The successful candidate will work in a dynamic academic environment, working across various...

Job Title: Head of Regulatory Affairs - Biologics and DermatologyCompany Overview: Join a leading biopharmaceutical company at the forefront of innovation in biologics and dermatology. Our client is committed to developing transformative therapies that address unmet medical needs and improve the lives of patients globally. Their is dedicated to pushing the...

Job Title: Head of Regulatory Affairs - Biologics and DermatologyCompany Overview: Join a leading biopharmaceutical company at the forefront of innovation in biologics and dermatology. Our client is committed to developing transformative therapies that address unmet medical needs and improve the lives of patients globally. Their is dedicated to pushing the...

Job Description Job Description Foster City, CA Contract Duration: 6-18 months Rate: Negotiable Responsibilities: Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLY Provide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of...

Job DescriptionJob DescriptionTitle: Senior/Executive Director Regulatory AffairsSummary: A growing immune-oncology company is seeking a Senior/Executive Director of Regulatory Affairs to join the team in executing regulatory strategies and supporting the development of their product pipeline with an emphasis on early stage development.The S/E Director of...

Reporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. **Responsibilities** - Prepare and/or coordinate and comply routine regulatory submissions and other...

Job DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...

Job DescriptionJob DescriptionFoster City, CAContract Duration: 6-18 monthsRate: NegotiableResponsibilities:Excellent employment opportunity for a Regulatory Affairs CMC Associate in the Foster City, CA area. Bay area candidates ONLYProvide Regulatory CMC support for biologic and small molecule drugs being evaluated or marketed for the treatment of oncology,...

We are seeking an experienced Senior Director or Vice President of Regulatory Affairs (DOE). As the head of Regulatory Affairs you will be responsible for leading and managing all aspects of Clinical and CMC Regulatory Affairs. The ideal candidate will have a strong background in cell therapy with experience in early development regulatory affairs (pre-IND...

Job DescriptionJob DescriptionSalary: $90KPurpose:The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system.Duties & Responsibilities: Review and approve audit agenda, plan, summary reports for internal audits. Facilitate and participate in external...

Job DescriptionJob DescriptionSalary: $90KPurpose:The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system.Duties & Responsibilities: Review and approve audit agenda, plan, summary reports for internal audits. Facilitate and participate in external...

Job DescriptionJob DescriptionSalary: $90KPurpose:The Regulatory Affairs Manager is responsible for managing the regulatory affairs department and functions to ensure regulatory compliance of quality management system.Duties & Responsibilities: Review and approve audit agenda, plan, summary reports for internal audits. Facilitate and participate in external...

Responsibilities and Duties:Responsible for timely planning, coordination, and execution of regulatory submissions to FDA and other jurisdictionsOversee the authoring, review, approval and submission of Clinical, Nonclinical, and CMC documents for regulatory submissionsConduct regulatory review of submission documentsCoordinate with external publishing...