Global Head Cell & Gene Therapy Regulatory

At Roche, we are committed to revolutionizing the field of healthcare through innovative treatments and therapies. As the Global Head Cell & Gene Therapy Regulatory, you will play a crucial role in shaping the future of medicine and improving the lives of patients worldwide. We are seeking a highly skilled and experienced regulatory professional who is passionate about advancing the development and commercialization of cell and gene therapies. With your expertise and leadership, you will drive regulatory strategy and ensure compliance with global regulations to bring life-saving treatments to market. Join our dynamic and diverse team at Roche and help us make a meaningful impact on the world.

1. Develop and implement global regulatory strategies for cell and gene therapies in collaboration with cross-functional teams.
2. Stay up-to-date on the latest regulatory requirements and guidelines related to cell and gene therapies, and proactively advise the company on potential impact and changes.
3. Lead and manage all aspects of the regulatory submission process, including preparation, review, and submission of regulatory documents to health authorities.
4. Act as the primary point of contact for all regulatory agencies and ensure timely and effective communication with them.
5. Maintain a strong understanding of the competitive landscape and regulatory environment for cell and gene therapies, and use this knowledge to inform and shape the company's strategy.
6. Develop and maintain relationships with key stakeholders, both internal and external, to ensure support for regulatory initiatives and alignment with company goals.
7. Provide regulatory guidance and expertise to cross-functional teams throughout the product development lifecycle, from preclinical to commercialization.
8. Ensure compliance with all applicable regulations and guidelines, and lead efforts to address any regulatory issues or challenges that may arise.
9. Collaborate with other departments, such as clinical, manufacturing, and quality, to ensure alignment and consistency in regulatory strategies and submissions.
10. Serve as a subject matter expert on cell and gene therapy regulatory requirements and provide training and mentorship to other team members.
11. Monitor and report on the progress of regulatory submissions and approvals, and provide regular updates to senior management.
12. Continuously evaluate and improve the company's regulatory processes and procedures, and identify opportunities for efficiency and optimization.
13. Represent the company at external meetings and conferences related to cell and gene therapy regulatory affairs.
14. Foster a culture of compliance and ethical behavior within the organization, and ensure adherence to Roche's values and code of conduct.

According to JobzMall, the average salary range for a Global Head Cell & Gene Therapy Regulatory in Basel, Switzerland is approximately CHF 220,000 to CHF 300,000 per year. However, salaries can vary depending on the specific company, level of experience, and qualifications of the individual. Additionally, bonuses and other benefits may also be included in the overall compensation package.

Roche Holding AG operates as a research healthcare company. It operates through the diagnostics and pharmaceuticals segments. The pharmaceutical segment refers to development of medicines in the field of oncology, immunology, ophthalmology, infectious diseases and neuroscience. The diagnostic segment refers to diagnosis of diseases through an in vitro diagnostics process.