Regulatory Affairs Manager

The Senior Manager, Regulatory Affairs will work with EU regulatory lead(s) and/or directly with global regulatory lead(s) and within cross-functional teams to facilitate submission of applications to EU and International health agencies (HA) for Alnylam’s RNAi therapeutics.  The role will work across programs to support the development of Alnylam’s products globally.  In doing so they are responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role will contribute to regulatory strategy and may represent the department on multidisciplinary product development subteams.  Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on EU regulatory requirements and internationally as relevant, and distributing regulatory intelligence to internal teams.

Summary of Key Responsibilities

• Work with EU/Global regulatory lead  to lead the planning, preparation (including authoring where relevant) and delivery of both simple and complex regulatory submissions throughout the product's life cycle.  This may include relevant forms, new Clinical Trial Applications (CTAs) responses to questions, substantial modifications, notifications etc, meeting requests, Briefing Documents for HA meetings.  Role may also include supporting preparation of  Paediatric Plans, Orphan Designation, Expedited Pathway Applications (e.g. PRIME), and Marketing Applications and any amendments.
• Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects.
• Serve as member of the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams for assigned programs and participate as an active team member and provide EU regulatory advice.
• 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 as necessary the 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.

Qualifications

• Bachelor's degree with 4 or more years of experience in a Regulatory Affairs strategy role working in the biotech or pharmaceutical industry. Advanced scientific degree preferred.
• 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 to proactively identify issues and mitigation strategies in various aspects of the drug development process.
• Experience with regulatory filings, including electronic submissions, e.g., CTAs, DSURs, post-marketing variations, paediatric plans, ODD 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 (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.
• Clear alignment with Alnylam Core Values including:
  o    Commitment to People,
  o    Fiercely Innovative,
  o    Purposeful Urgency,
  o    Open Culture, and 
  o    Passion for Excellence.

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.

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