Associate Director, Regulatory Affairs

Job Title: Associate Director, Regulatory Affairs Germany

Location: Germany (Hybrid) 2x days week in our Munich office

The Associate Director, Regulatory Affairs Germany is a key strategic leadership role with full accountability for national regulatory strategy, execution, and authority engagement. This role is pivotal in translating the global Alnylam regulatory strategy to the local German level, driving cross-functional collaboration, and enabling the successful execution of business objectives, such as product launches and lifecycle management.

We are seeking a forward-thinking leader who can shape regulatory direction, influence internal and external stakeholders, and lead with agility in a complex and evolving regulatory environment.

Key Responsibilities

Strategic Leadership

• 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

Functional Ownership

• 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

Cross-Functional Influence

• 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

Qualifications

• 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)

Join a company recognized for its innovation, open culture, and commitment to people. At Alnylam, you'll work in an environment that values collaboration, purpose, and excellence — and be part of a team bringing groundbreaking RNAi therapies to patients in need.

Apply now to make a difference where science meets purpose.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture: Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK – among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.