Regulatory Strategy Associate Director

About the role

The Regulatory Strategy Associate Director will join Vertex's Global Regulatory Affairs team, reporting to the Senior Director of Regulatory Affairs. Based in Switzerland, this role provides regional and local regulatory expertise to ensure compliance with national requirements and to support the company’s strategic objectives.

Key responsibilities

• Serve as the primary contact with Swissmedic for all regulatory activities.
• Track and forward national health authority requests and new legislation to the Global Regulatory Affairs team.
• Maintain up‑to‑date knowledge of Swiss regulatory requirements and communicate changes to senior management.
• Obtain regulatory intelligence through interaction with Swissmedic.
• Provide expert advice on queries from medical, supply chain and other functions (e.g., compassionate use, labeling exemptions).
• Lead submission, follow‑up and variation management of national Marketing Authorization Applications (MAAs) for products approved in Switzerland.
• Review and approve translations for labeling, artwork and product information.
• Assess promotional material against local regulations (AWV, Pharma Code).
• Participate in cross‑functional launch activities and ensure compliance with company policies.

Required profile

• Extensive experience in regulatory affairs across the product lifecycle, with a focus on Swiss regulations.
• Recognised as a go‑to resource for regulatory advice within an organization.
• Proven ability to manage complex negotiations with health authorities.
• Strong capability to collaborate with international regulatory teams, internal departments and external stakeholders.
• Commitment to supporting innovative therapies for serious diseases.

Required skills

What we offer

• Opportunity to work on cutting‑edge therapies within a global biotech leader.
• Collaborative environment with cross‑functional teams.
• Competitive compensation and benefits package.