Gilead Sciences

Director, Global Regulatory Affairs, Precision Medicine

Gilead Sciences

Foster City, CA, USA
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to Gilead Sciences, where we are dedicated to advancing innovative and life-saving therapies for patients around the world. We are seeking a highly experienced and driven Director, Global Regulatory Affairs, Precision Medicine to join our team. In this role, you will play a critical role in shaping and executing our regulatory strategies for our precision medicine portfolio. As a leader in our global regulatory affairs team, you will collaborate with cross-functional teams to ensure compliance with all applicable regulations and drive successful submissions to health authorities. If you are a strategic thinker with a passion for precision medicine and a strong track record of success in regulatory affairs, we invite you to apply for this exciting opportunity.

  1. Develop and execute global regulatory strategies for precision medicine portfolio.
  2. Collaborate with cross-functional teams to ensure compliance with all applicable regulations.
  3. Lead the preparation and submission of regulatory documents to health authorities.
  4. Stay up-to-date with relevant regulations and guidelines and communicate any changes to internal stakeholders.
  5. Serve as the primary point of contact for health authorities regarding precision medicine regulatory matters.
  6. Provide guidance and expertise to internal teams on regulatory requirements for precision medicine.
  7. Develop and maintain relationships with key stakeholders, including health authorities, to advance regulatory strategies.
  8. Identify and mitigate potential regulatory risks for the precision medicine portfolio.
  9. Monitor and track regulatory submissions and ensure timely and successful approvals.
  10. Lead and mentor a team of regulatory professionals to achieve departmental and company goals.
  11. Participate in cross-functional meetings and provide regulatory guidance and support to project teams.
  12. Represent the company at external meetings and conferences related to precision medicine regulatory affairs.
  13. Communicate regulatory updates and progress to senior management and other relevant stakeholders.
  14. Collaborate with other departments to ensure accurate and timely reporting of regulatory submissions and approvals.
  15. Maintain a thorough understanding of the company's precision medicine products and their associated regulatory requirements.
  16. Continuously evaluate and improve processes and procedures related to precision medicine regulatory affairs.
  17. Ensure compliance with all company policies and procedures related to regulatory affairs.
  18. Act as a subject matter expert for precision medicine regulatory affairs within the company.
  19. Foster a culture of continuous learning and development within the team.
  20. Provide input and support for budget planning and resource allocation for precision medicine regulatory affairs.
Where is this job?
This job is located at Foster City, CA, USA
Job Qualifications
  • Extensive Knowledge And Experience In Precision Medicine: The Ideal Candidate For This Position Should Have A Deep Understanding Of Precision Medicine And Its Regulatory Landscape. This Includes Understanding Of Biomarkers, Companion Diagnostics, And Personalized Therapies.

  • Leadership And Management Skills: As A Director, Global Regulatory Affairs, This Individual Will Be Responsible For Managing A Team And Overseeing Global Regulatory Strategies And Submissions. Therefore, Strong Leadership And Management Skills Are Essential For This Role.

  • Regulatory Expertise: The Candidate Should Have A Strong Background And Expertise In Global Regulatory Affairs, Specifically In The Areas Of Drug Development, Clinical Trials, And Approvals. Familiarity With Regulatory Agencies Such As Fda, Ema, And Pmda Is Also Important.

  • Strong Communication And Interpersonal Skills: The Director, Global Regulatory Affairs, Will Be Required To Communicate With Various Internal And External Stakeholders, Including Regulatory Agencies, Cross-Functional Teams, And Industry Partners. Therefore, Excellent Communication And Interpersonal Skills Are Crucial For This Role.

  • Advanced Degree In A Relevant Field: A Degree In A Relevant Field Such As Pharmacy, Pharmaceutical Sciences, Or Life Sciences Is Typically Required For This Position. A Post-Graduate Degree Or Additional Certifications In Regulatory Affairs Or Precision Medicine Would Be Considered A Plus.

Required Skills
  • Cross-Functional

  • Drug development

  • Regulatory compliance

  • FDA regulations

  • Clinical Trials

  • Regulatory Strategy

  • Precision Medicine

  • Labeling Requirements

  • Global Submissions

  • Health Authority Interactions

  • Ema Regulations

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • Interpersonal Skills

  • creativity

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Director, Global Regulatory Affairs, Precision Medicine in Foster City, CA, USA is $184,000 - $294,000 per year. This salary range may vary based on the individual's experience, education, and skills. Additionally, factors such as the company's size and industry may also impact salary.

Additional Information
Gilead Sciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedJuly 2nd, 2024
Apply BeforeSeptember 18th, 2025
This job posting is from a verified source. 
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About Gilead Sciences

Gilead Sciences, Inc., is an American biotechnology company that researches, develops and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

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