Job Description
General Summary:
- Reporting to the Senior Director of Regulatory Affairs and partnering closely with the cross-functional leadership team and the Swiss Country Manager, the Country Associate Director (AD) of Regulatory Affairs will act as a local strategic leader and key partner within the International Regulatory Affairs team. This role is critical in shaping and executing the regulatory strategy for Switzerland, ensuring alignment with global objectives while addressing local regulatory requirements.
The AD will demonstrate leadership, accountability, and collaboration to drive impactful outcomes for Vertex and its stakeholders.
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Key Duties And Responsibilities
Regulatory
- Inform the development and execution of innovative regulatory strategies to support product launches, lifecycle management, and compliance initiatives.
- Translate the global regulatory strategy into actionable plans tailored to the Swiss regulatory environment, ensuring alignment with corporate goals.
- Act as a strategic advisor to local senior leadership, providing insights and recommendations to anticipate and address regulatory trends.
- Shape regulatory direction by influencing internal and external stakeholders, ensuring Vertex is positioned for success in the Swiss market.
- Serve as the primary liaison with Swissmedic, leading all regulatory interactions, negotiations, and meetings with a focus on building trusted relationships.
- Take full ownership of regulatory planning and execution for local Marketing Authorization Applications (MAAs), lifecycle management submissions, and compliance with national requirements.
- Ensure timely and accurate communication of regulatory intelligence, legislative changes, and health authority requests to internal stakeholders.
- Oversee the review and approval of promotional, medical, and educational materials, ensuring compliance with local regulations.
General
- Actively engage with local cross-functional teams, including Commercial, Medical Affairs, Market Access, Quality, and Supply Chain, to align regulatory priorities with business objectives.
- Represent Regulatory Affairs in local cross-functional forums, driving alignment and shared accountability across teams.
- Build and maintain strong partnerships with external consultants, industry stakeholders, and trade associations to advance regulatory objectives
Contribute to cross-functional launch activities, ensuring regulatory readiness and operational excellence.
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Knowledge And Skills
Regulatory
- Extensive experience in regulatory affairs, with a proven track record of strategic leadership and successful regulatory negotiations.
- In-depth knowledge of the Swiss regulatory environment, including requirements for innovative products across development and post-authorization phases.
- Ability to influence internal and external stakeholders, with strong communication and presentation skills.
- Demonstrated capacity to navigate complex, fast-paced environments with resilience, adaptability, and a focus on delivering high-quality results.
- Commitment to fostering a collaborative and inclusive work environment, aligned with Vertex’s core values.
General
- Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
- Good interpersonal skills and ability to deal effectively with a variety of personalities
- Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements
- Self-motivated with the ability and desire to take on new challenges, to help build an organization and still be part of a team taking a hands-on approach to projects.
- Team player, but also able to behave independently where needed, at the same time this individual must understand and embrace being part of a team and working collaboratively with others.
- Strong analytical ability; and an ability to deal with ambiguity, uncertainty and complexity
- Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct.
- Ability to navigate and be successful in a fast-paced environment while delivering high quality results.
- Accountability - ensuring assigned projects are appropriately prioritised and progressed in accordance with agreed regulatory plans
Education And Experience
- Bachelor’s degree in life sciences required; advanced degree ( M.Sc . or Ph.D.) preferred.
- Significant experience in regulatory affairs, with a focus on strategic leadership and cross-functional collaboration.
- Fluency in written and spoken English; proficiency in German is highly desirable.
Flex Designation
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status
In this Hybrid-Eligible role, you can choose to be designated as:
- Hybrid: work remotely up to two days per week; or select
- On-Site: work five days per week on-site with ad hoc flexibility.
- Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-SG1
#LI-Hybrid
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid : work remotely up to two days per week; or select
2. On-Site : work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]
