Manager, Regulatory Affairs

Overview

Alnylam is the world’s leading RNA interference (RNAi) company.

Founded in 2002, Alnylam was built upon a bold vision of turning scientific possibility into reality by harnessing the power of RNAi for human health as an innovative new class of medicines. We are a growing biopharmaceutical company with two approved medicines and a robust pipeline of investigational medicines focused in four strategic therapeutic areas: genetic medicines, cardio-metabolic diseases, infectious diseases, and central nervous system (CNS) and ocular diseases, including several in late-stage development.

Headquartered in Cambridge, Mass., Alnylam employs over 1,400 people in 19 countries and is rapidly growing globally, with additional offices in Norton, Mass., Maidenhead, U.K., Zug, Switzerland, Amsterdam, Netherlands, and Tokyo, Japan. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work five years in a row (2015-2019), a Great Place to Work in the U.K. and Switzerland in 2020 and Science Magazine’s #1 Top Employer in 2019. Please visit www.alnylam.com for more information.

The Manager of Regulatory Affairs will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to define the regulatory strategy, facilitate submission of data packages to the FDA, EMA and other international health agencies (HA). The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role may serve as regulatory representative on multidisciplinary product development sub-teams and core teams. The role may also serve as US Regional Lead for marketed product or Regulatory Program Lead for early programs in Alnylam pipeline. 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 regulatory requirements worldwide, and distributing regulatory intelligence to the internal teams.

Summary of Key Responsibilities

• Work with the Global Regulatory Lead and Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs, INDs), Marketing Applications, Pediatric Plans, Orphan Designation and Expedited Pathway 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 or core team for assigned programs and participate as an active team member.

• May serve as US 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.

• 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 as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.

  
  

Qualifications

• Bachelor's degree with 4+ years’ experience in a Regulatory Affairs role; minimum of 6 years’ experience working in the biotech or pharmaceutical industry. OR PhD/PharmD with a minimum of 1-2 years in the 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 to proactively identify issues and mitigation strategies in various aspects of the drug development process.
• Experience with regulatory filings, including electronic submissions, e.g., INDs, CTAs, 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 (e.g., word processing, spreadsheets, databases, online research) including submission-ready formatting.
• RAC certification and/or advanced degree are preferred
• Clear alignment with Alnylam Core Values including:
  • Commitment to People,
  • Innovation and Discovery,
  • Sense of Urgency,
  • Open Culture
  • Passion for Excellence.
• If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.