Associate Director, Local Regulatory Lead - Switzerland and Austria
In this hybrid leadership role you drive local regulatory strategy and execution for Switzerland and Austria, translating global objectives into country-specific plans. You act as the regulatory partner to senior leadership, anticipate trends, and guide cross-functional teams to enable product launches and lifecycle submissions. You will manage interactions with Swissmedic and AGES, and ensure compliance across regulatory, quality, and supply chain activities. This position offers strategic influence in a fast-changing market and a chance to shape local regulatory direction within a global biotech leader.
Translate global regulatory strategy into country-specific execution aligned with EU and affiliate objectives
Serve as primary liaison with Swissmedic and AGES, leading regulatory interactions and negotiations
Own regulatory planning and execution for local MA submissions and lifecycle management in Switzerland and Austria
Oversee regulatory review and approval of promotional, medical, and educational materials
Provide regulatory input into supply chain and quality operations (GMP/GDP licensing and distribution readiness)
Drive implementation of regulatory systems and processes to ensure compliance and transparency
Represent Global Regulatory Sciences in local cross-functional forums to shape priorities
Lead cross-functional regulatory initiatives within the affiliate across Commercial, Medical Affairs, Market Access, Quality, and Supply Chain
Build partnerships with external consultants, CROs, and industry stakeholders to advance regulatory objectives
Monitor local legislation and regulatory guidance development as part of cross-industry associations (where assigned)
University degree in life sciences, pharmacy, medicine or related field (MSc, PharmD, MD); advanced degree preferred (PhD)
At least 8 years in Regulatory Affairs within pharma/biotech, including national regulatory leadership in Switzerland
Proven success in regulatory negotiations and relationships with Swiss health authorities
Deep understanding of Swiss and EU regulatory environment for development and post-approval, including promotion and compliance
Ability to lead cross-functional teams, influence senior stakeholders, and drive strategic alignment
Excellent communication skills in German and English (written and spoken)
High initiative, resilience, and adaptability in a fast-paced, high-visibility setting
Willingness to travel approx. once per month
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