Technical Regulatory Program Director (Cellular Therapies)

Welcome to Genentech, where we strive to break new ground in the field of cellular therapies and improve the lives of patients worldwide. We are currently seeking a highly skilled and experienced Technical Regulatory Program Director to join our team and lead our efforts in obtaining necessary regulatory approvals for our cutting-edge cellular therapies. As the Technical Regulatory Program Director, you will play a critical role in shaping the future of this rapidly advancing field and ensuring the success of our groundbreaking therapies. We are looking for a driven and knowledgeable individual who possesses a deep understanding of regulatory requirements and a passion for revolutionizing the treatment of diseases. If you are ready to make a significant impact in the world of cellular therapies, then we invite you to apply for this exciting opportunity.

1. Develop and implement regulatory strategies to support the approval of cellular therapies in various global markets.
2. Collaborate with cross-functional teams, including research and development, clinical, and manufacturing, to ensure regulatory compliance and successful product development.
3. Stay up-to-date with evolving regulatory requirements and communicate changes and updates to relevant stakeholders.
4. Lead the preparation and submission of regulatory documents, including INDs, BLAs, and NDAs.
5. Review and provide input on clinical protocols, study reports, and other technical documents to ensure alignment with regulatory requirements.
6. Conduct risk assessments and develop mitigation plans to address potential regulatory challenges.
7. Serve as the primary point of contact for regulatory agencies and lead interactions during regulatory inspections.
8. Develop and maintain relationships with key stakeholders, including regulatory agencies, industry partners, and advocacy groups.
9. Oversee the preparation and maintenance of regulatory submissions and ensure timely completion.
10. Lead and manage a team of regulatory professionals, providing guidance and direction on regulatory strategies and processes.
11. Monitor and analyze regulatory trends and developments to inform decision-making.
12. Represent the company at industry conferences and meetings to stay abreast of industry best practices and share insights on regulatory topics.
13. Ensure compliance with all applicable laws, regulations, and company policies.
14. Identify and implement process improvements to enhance efficiency and quality in regulatory submissions and approvals.
15. Act as a subject matter expert on regulatory requirements and provide guidance and training to cross-functional teams.

According to JobzMall, the average salary range for a Technical Regulatory Program Director (Cellular Therapies) in South San Francisco, CA, USA is $162K - $189K per year. This may vary depending on the specific company, years of experience, and level of education and skills of the individual.

Genentech, Inc., is a biotechnology corporation which became a subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche. As of February 2020, Genentech employed 13,638 people.