Job Description

Translate the global regulatory strategy and lead the country-specific regulatory execution in alignment with global, EU and affiliate's objectives Act as a strategic advisor to Country General Manager and senior cross-functional leaders Anticipate regulatory trends and proactively position Alnylam for success in the Swiss/Austrian markets Translate complex regulatory landscape into actionable business plans and risk mitigation strategies 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 the pharmaceutical or biotech industry, including strategic leadership of national regulatory activities in Switzerland is a must Proven success in leading regulatory negotiations and building trusted relationships with the Swiss/Austrian health authorities Deep understanding of the Swiss and EU regulatory environment, including requirements for innovative products across development and post-approval phases; promotional and compliance requirements and standards Demonstrated ability to work with cross-functional teams, influence senior stakeholders, and drive strategic alignment Excellent communication skills with fluency in German and English (written and spoken) High degree of initiative, resilience, and adaptability in a fast-paced, high-visibility setting Willingness to travel as needed (approx. once per month) Serve as the primary liaison with Swiss (Swissmedic) and Austrian (AGES) health authorities, leading all regulatory interactions, negotiations, and meetings Own the regulatory planning and execution for local MA submissions in Switzerland, life-cycle management submissions, as well and product launches and compliance initiatives for the regulatory area (in both Switzerland and Austria) Lead the regulatory review and approval of promotional, medical, and educational materials, ensuring alignment with local regulations and strategic imperatives Provide regulatory input into supply chain and quality operations, including GMP/GDP licensing and distribution readiness as required Drive implementation of regulatory systems and processes, ensuring operational excellence, compliance and transparency Represent Global Regulatory Sciences in strategic local cross-functional forums, shaping priorities and aligning teams around shared goals Lead cross-functional regulatory initiatives within the affiliate, integrating perspectives from Commercial, Medical Affairs, Market Access, Quality, and Supply Chain Build and maintain strong partnerships with external consultants, CROs, and industry stakeholders to advance regulatory objectives Represents Alnylam in local cross-industry associations (if assigned), monitors and participates in shaping of upcoming local legislation and regulatory guidance development

Skills Required