Senior Director, CMC Regulatory Affairs

Are you a seasoned regulatory professional with a strong background in CMC (Chemistry, Manufacturing, and Controls)? Are you looking for a leadership role where you can make a significant impact in the pharmaceutical industry? Look no further! Gilead Sciences is seeking a highly qualified Senior Director to join our dynamic team and lead our CMC Regulatory Affairs department. In this role, you will oversee the development and execution of global regulatory strategies for our innovative products. We are seeking a candidate with a deep understanding of regulatory requirements and a proven track record of success in regulatory submissions and approvals. If you are a strategic thinker, a collaborative leader, and a subject matter expert in CMC regulatory affairs, we encourage you to apply for this exciting opportunity.

1. Develop and execute global regulatory strategies for innovative products in compliance with applicable regulations and guidelines.
2. Lead and manage the CMC Regulatory Affairs department, providing strategic direction and guidance to team members.
3. Serve as the primary point of contact for all CMC regulatory matters with regulatory authorities, ensuring effective communication and timely submissions.
4. Collaborate cross-functionally with internal teams, including R&D, Manufacturing, Quality, and Commercial, to ensure alignment on regulatory strategies and submissions.
5. Monitor and interpret regulatory guidelines and requirements, and proactively identify potential risks and opportunities for the organization.
6. Oversee the preparation and submission of high-quality regulatory documents, including INDs, NDAs, and MAAs.
7. Ensure compliance with regulatory requirements and timely completion of regulatory submissions and approvals.
8. Represent the company in regulatory meetings and discussions with health authorities, providing expertise and guidance on CMC regulatory matters.
9. Develop and maintain strong relationships with regulatory authorities, industry associations, and external partners to stay updated on regulatory developments and best practices.
10. Mentor and develop team members, fostering a culture of continuous learning and growth within the CMC Regulatory Affairs department.
11. Partner with other senior leaders to develop and implement regulatory strategies that support the company's overall business goals.
12. Monitor and manage the CMC regulatory budget, ensuring efficient use of resources and cost-effective strategies.
13. Act as a subject matter expert on CMC regulatory affairs, providing guidance and expertise to internal and external stakeholders.
14. Continuously evaluate and improve processes and procedures within the CMC Regulatory Affairs department to enhance efficiency and productivity.
15. Stay current with industry trends and best practices in CMC regulatory affairs, and provide recommendations for process improvements and innovation.

According to JobzMall, the average salary range for a Senior Director, CMC Regulatory Affairs in Foster City, CA, USA is between $225,000 - $250,000 per year. This range can vary depending on the specific company, experience level, and other factors.

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.