Regulatory Affairs (Project) Manager

Welcome to Roche, a global pioneer in healthcare and pharmaceuticals. We are currently seeking a highly qualified and motivated individual to join our team as a Regulatory Affairs (Project) Manager. In this role, you will play a critical role in ensuring the compliance of our products with relevant laws and regulations, as well as supporting the successful registration and commercialization of new products. As a member of our Regulatory Affairs team, you will have the opportunity to make a meaningful impact on the lives of patients around the world. We are looking for individuals with a deep understanding of global regulatory requirements and a strong track record of successfully managing projects in a fast-paced environment. If you are passionate about making a difference in the healthcare industry and possess the necessary skills and experience, we encourage you to apply for this exciting opportunity.

1. Ensure compliance with relevant laws and regulations for all products.
2. Support the registration and commercialization of new products.
3. Manage and oversee all regulatory aspects of assigned projects.
4. Keep up-to-date with global regulatory requirements and changes.
5. Develop and maintain strong relationships with regulatory authorities.
6. Provide guidance and support to cross-functional teams on regulatory matters.
7. Prepare and submit necessary documentation for product registrations.
8. Manage timelines and ensure timely submission of regulatory documents.
9. Collaborate with internal stakeholders to ensure alignment on regulatory strategies.
10. Conduct regulatory risk assessments and develop mitigation plans.
11. Monitor and track regulatory submissions and approvals.
12. Communicate updates and changes in regulatory requirements to internal teams.
13. Conduct training sessions for team members on regulatory processes and requirements.
14. Participate in regulatory agency meetings and inspections.
15. Ensure compliance with Roche's internal policies and procedures.
16. Identify and implement process improvements for regulatory processes.
17. Maintain accurate and organized records of regulatory submissions and approvals.
18. Stay updated on industry trends and changes in regulations.
19. Provide support for regulatory audits and inspections.
20. Act as a representative for Roche in industry conferences and meetings related to regulatory affairs.

According to JobzMall, the average salary range for a Regulatory Affairs (Project) Manager in Basel, Switzerland is between CHF 120,000 and CHF 160,000 per year. This can vary depending on factors such as experience, specific industry, and company size.

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.