Associate Director Regulatory Affairs

Overview

The Associate Director of Regulatory Affairs Strategy will serve as US Regional Lead or Global Regulatory Lead for our early/mid/late-stage CNS programs. The role will lead the regulatory strategy and facilitate submission of data packages to the US. 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 will represent RA on multidisciplinary product development subteams and Global Regulatory Team. 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 US regulatory requirements, and interpreting regulatory intelligence for the internal teams.

Summary of Key Responsibilities

• Serve as US Regional Lead or Global Regulatory Lead for our early/mid/late-stage CNS programs.
• Lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead US HA interactions. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new INDs, Marketing Applications, Pediatric Plans, Orphan Designation and Expedited Pathway Applications (e.g. Breakthrough Designation).
• Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects.
• Serve as member of/or lead 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.
• 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 6 or more years of experience in a Regulatory Affairs role; minimum of 8 years’ experience 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 to proactively identify issues and mitigation strategies in various aspects of the drug development process.
• Experience with US regulatory filings.
• Experience with leading interactions with US FDA.
• 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.