Associate Director, Local Regulatory Lead

This role is considered [[custWorkplaceType]].

Overview

The Associate Director, Local Regulatory Lead – Switzerland and Austria is a strategic leadership role with full accountability for national regulatory strategy, execution, and health authority engagement.

This role serves as the business-facing regulatory leader in the affiliate who is pivotal in aligning local regulatory operations by translating the global Alnylam regulatory strategy to local level, driving cross-functional collaboration, and enabling successful execution of the business objectives (e.g. product launches and lifecycle submissions' management) in the assigned countries. The role demands a forward-thinking leader who can shape regulatory direction, influence internal and external stakeholders, and lead with agility in a complex and evolving environment.

This position is hybrid onsite and remote working and will be primarily located at Zug, Switzerland.

Key Responsibilities

• Strategic Leadership
• 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

• Functional Ownership

• 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

• 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, 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)

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.