Associate Director, Regulatory Affairs

Translate the global regulatory strategy and and lead the country-specific regulatory strategy execution in alignment with global, EU and affiliate's objectives Act as a strategic advisor to Country General Managers and senior cross-functional leaders Anticipate regulatory trends and proactively position Alnylam for success in the German market Translate complex regulatory landscapes into actionable business plans and risk mitigation strategies University degree in Life Sciences or a related field; advanced degree preferred 10+ years of highly relevant experience in Regulatory Affairs within the pharmaceutical and biotechnology industries, including strategic oversight of national regulatory submissions, compliance frameworks, and agency interactions aligned with evolving regulatory landscapes Proven success in leading regulatory negotiations and building trusted relationships with German health authorities Deep understanding of the German regulatory environment, including requirements for innovative products across development and post-approval phases; promotional and compliance requirements and standards Demonstrated ability to lead 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 German health authorities (e.g., BfArM, PEI), leading all regulatory interactions, negotiations, and meetings Own the regulatory planning and execution for local product launches, national regulatory submission (e.g. PZN codes, RMP educational materials etc.), and compliance initiatives Lead the regulatory review and approval of promotional, medical, and educational materials, ensuring alignment with local regulations and strategic messaging Provide regulatory input into supply chain and quality operations, including GMP/GDP licensing and distribution readiness 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