Alnylam Pharmaceuticals · 16 hours ago
Associate Director, Regulatory Affairs
Cambridge, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$164K/yr - $222K/yr
6+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, dedicated to transforming lives through innovative science. The Associate Director of Regulatory Affairs Strategy will define regulatory strategies, coordinate regulatory submissions, and serve as a liaison with health authorities to support product development and clinical trials.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
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
Work with the Global Regulatory Lead and Regulatory Affairs management to 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, Investigational New Drug (IND) applications, new Clinical Trial Applications (CTAs), New Drug Applications (NDAs), Pediatric Plans, Orphan Designation and Expedited Pathway Applications (Breakthrough, Fast Track), 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
Participate as an active team member and 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
Provide US specific regulatory intelligence to internal stakeholders as appropriate
Qualification
Required
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 regulatory filings, including electronic submissions, e.g., INDs, CTAs, 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
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
A 401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase