Associate Director, Regulatory Affairs

Alnylam Pharmaceuticals

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer and leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating breakthrough science into transformational medicines for patients worldwide. Historically focused on rare and genetic diseases, our scientific advances now enable us to bring RNAi therapeutics to more prevalent diseases, unlocking the full potential of this new class of medicines. Founded in 2002, Alnylam has grown to over 1,650 employees globally and is committed to fostering a diverse, equitable, and inclusive work environment.

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• Serve as EU Regional Lead for assigned program, or as Regulatory Program Lead, leading the Global Regulatory Team for one of the early programs in the Alnylam pipeline.
  
• Work with the Global Regulatory Lead and Regulatory Affairs management to define regulatory strategy and to compile and submit regulatory documents in a timely manner, leading EU HA interactions. Documents include relevant forms, meeting requests, briefing documents for HA meetings, new Clinical Trial Applications (CTAs), Marketing Applications, Paediatric Plans, Orphan Designation and Expedited Pathway Applications, and any amendments.
  
• Develop detailed regulatory project plans and support regulatory activities for specific portfolio products/projects.
  
• Serve as a member of the Global Regulatory Team; may serve as Regulatory representative on multidisciplinary product subteams or core teams for assigned programs.
  
• Provide strategic regulatory advice to project teams.
  
• Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.
  
• Serve as a liaison within internal departments at Alnylam, with CROs, and with regulatory program managers at HAs.
  
• Maintain regulatory files in a format consistent with internal requirements.
  
• Facilitate review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.
  
• Provide EU specific regulatory intelligence to internal stakeholders as appropriate.
  

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• Bachelor's degree with extensive knowledge/experience in a Regulatory Affairs role working in the biotech or pharmaceutical industry.
  
• Excellent written and verbal communication skills, including negotiation and influencing skills.
  
• Solid understanding of regulations and experience in interpretation of guidelines.
  
• Ability to think strategically and proactively identify issues and mitigation strategies in various aspects of the drug development process.
  
• Experience with regulatory filings, including electronic submissions such as CTAs, post‑marketing variations, annual reports, safety reporting, etc.
  
• Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.
  
• Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.
  
• Technical system skills (word processing, spreadsheets, databases, online research) including submission‑ready formatting.
  
• Clear alignment with Alnylam Core Values, which include:
  – Commitment to People
  – Fiercely Innovative
  – Purposeful Urgency
  – Open Culture
  – Passion for Excellence
  

Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a 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. Since our founding in 2002, we have led the RNAi Revolution and continue to turn scientific possibility into reality.

Our people‑first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. These values influence how we work and the business decisions we make. We are proud to have been recognized as one of Science Magazine’s Top Biopharma Employers, a Fast Company Best Workplace for Innovators, and a Great Place to Work in multiple countries.

Alnylam is committed 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 their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger and we bring groundbreaking medicines to patients.