Senior Manager, Regulatory Strategy

Senior Manager- Regulatory Strategy, EU

Overview

The Senior Manager of Regulatory Affairs will report to the Director, Regulatory Affairs (RA) and will work with Global/EU regulatory lead, the program Leadership Team and other 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 Global/EU regulatory lead to define regulatory strategy and 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, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs, INDs) and substantial modifications etc, Paediatric Plans, Orphan Designation, Expedited Pathway Applications (e.g. PRIME), and Marketing Applications and any amendments.

• Develop detailed regulatory strategy and project plans and support regulatory activities relating to specific portfolio of products/projects.
• Serve as member of the Global Regulatory Team, serve as Regulatory representative in multidisciplinary product subteams for assigned programs and participate as an active team member and provide strategic 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:
• Commitment to People,
• Fiercely Innovative,
• Purposeful Urgency,
• Open Culture, and
• Passion for Excellence.