Manager, Regulatory Affairs (Life Cycle Management)

Manager of Regulatory Affairs – Life Cycle Management

Overview:

The Manager of Regulatory Affairs will be a key member of the Regulatory Life Cycle Management team (LCM) and 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 EMA and support regulatory strategy and submissions in other international health Agencies (HA), such as MHRA, Health Canada, Swissmedic etc.  The role is responsible for planning and coordinating all aspects of regulatory strategy for upcoming submissions necessary to support product registration and post-approval life cycle activities.  The role may serve as regulatory representative on multidisciplinary product development sub-teams and core teams. Additional responsibilities include involvement in the writing and oversight of regulatory dossier sections for submissions (performed by the CRO or internally), coordinating all aspects of eCTD regulatory submissions, proactively keeping up to date 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 include (not limited to), relevant regulatory forms, briefing documents, Agency meeting requests etc.
• Responsible for regulatory post-approval life cycle management activities, such as variations, renewals, maintenance of Pediatric Plans etc.
• Develop 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 sub-teams or core team for assigned programs and participate as an active team member.
• Provide strategic regulatory advice to project teams.
• Coordinate submissions and responses to regulatory authorities’ questions with strict adherence to deadlines across the international region.
• Serve as a liaison within internal departments at Alnylam, with CROs/consultants and with regulatory program managers at EMA or with the local affiliate regulatory leads within Alnylam.
• Maintain regulatory records consistent with internal standards and procedures.
• Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.

Qualifications:

• Master’s degree in life science discipline as a minimum (e.g. Biology, Pharmacy, Biotechnology or similar) advanced degree will be beneficial.
• Minimum of 6 years’ experience as Regulatory lead across various regions (at least within the EU, other regional experience is a plus) within innovative biopharma or CROs.
• Relevant experience in post approval life cycle management.
• Excellent written and verbal communication skills, including negotiation and influencing skills.
• Solid understanding of regulations within the region (EU, UK as a minimum) and experience in interpretation of guidelines across international markets.
• 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., variations, renewals, 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 incl. agentic AI use).
• Additional professional qualifications, e.g. RAC certification etc., will be beneficial
• Clear alignment with Alnylam Core Values including:
  • Commitment to People,
  • Fiercely Innovative
  • Open Culture
  • Passion For Excellence
  • Purposeful Urgency

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