Head of Regulatory Affairs Evionnaz

This role is available in either Evionnaz or Zofingen.

1. Define and implement regulatory strategies for new development projects and post-approval changes, ensuring alignment with business objectives.
2. Ensure the timely preparation and maintenance of high-quality regulatory dossiers in compliance with global standards (ICH, EU, US, and other national regulations).
3. Advise internal and external stakeholders on regulatory requirements and strategies, providing expert guidance throughout product development and lifecycle management.
4. Represent the regulatory function in cross-functional teams, ensuring regulatory requirements are integrated into product development and project timelines.
5. Review and process Change Control Requests, advising on necessary supporting data and ensuring the timely submission of amended dossiers.
6. Monitor, assess, and implement new regulations and guidelines (Regulatory Intelligence), ensuring that the company remains compliant and competitive in global markets.
7. Support external customers with their regulatory procedures, including preparing responses to regulatory queries and deficiency lists.
8. Contribute to process improvement initiatives within the Regulatory Affairs Leadership Team (RALT), driving regulatory process efficiency and harmonization.
9. Coach and mentor regulatory team members, fostering professional development and ensuring a high standard of performance within the department.
10. Maintain registration status overviews for all products and ensure that product-related documentation is continuously updated.