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.

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.
• Capture and 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.

Additional Information

U.S. Pay Range: $170,900.00 - $231,300.00
The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education.
This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k) with a generous company match.
Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.