Associate Director, Regulatory Affairs
Alnylam Pharmaceuticals
August 20, 2026
Remote friendly (Cambridge, MA)
United States
Corporate Functions
Associate Director of Regulatory Affairs Strategy will serve as US Regional Lead or Global Regulatory Lead for early/mid/late-stage CNS programs. Lead regulatory strategy and coordinate submission of data packages to the US. Plan and coordinate regulatory submissions to support product development, clinical trials, and product registration. Represent Regulatory Affairs on multidisciplinary product development subteams and the Global Regulatory Team.
Hybrid: 2 days/week onsite in Cambridge, MA or Philadelphia, PA.
Summary of Key Responsibilities:
- Serve as US Regional Lead or Global Regulatory Lead for assigned CNS programs.
- Lead/define regulatory strategy; compile and submit regulatory documents (forms, meeting requests, HA briefing documents, new INDs, marketing applications, pediatric plans, orphan designation, expedited pathway applications).
- Develop regulatory project plans for assigned portfolio.
- Serve on/lead the Global Regulatory Team; act as regulatory representative on product subteams/core teams.
- Coordinate timely responses to regulatory authority questions.
- Liaise with internal departments, CROs, and regulatory program managers at Health Authorities.
- Maintain regulatory files per internal requirements.
- Oversee/ensure review of technical regulatory documentation; recommend documentation/process (SOP) changes.
- Provide EU regulatory intelligence as appropriate.
Qualifications:
- Bachelor’s degree; 6+ years in Regulatory Affairs (minimum 8 years in biotech/pharmaceutical).
- Excellent written/verbal communication, negotiation, and influencing skills.
- Solid understanding of regulations and guideline interpretation; strategic, proactive issue identification and mitigation.
- Experience with US regulatory filings and leading interactions with FDA.
- Strong organizational/project management; ability to prioritize multiple projects.
- Teamwork/interpersonal skills with internal teams and CROs.
- Technical system skills for submission-ready formatting.
Benefits: Eligible for annual short-term incentive and annual long-term incentive; comprehensive benefits include medical/dental/vision, life/disability, reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, and family resources.
U.S. Pay Range: $170,900.00–$231,300.00.
Hybrid: 2 days/week onsite in Cambridge, MA or Philadelphia, PA.
Summary of Key Responsibilities:
- Serve as US Regional Lead or Global Regulatory Lead for assigned CNS programs.
- Lead/define regulatory strategy; compile and submit regulatory documents (forms, meeting requests, HA briefing documents, new INDs, marketing applications, pediatric plans, orphan designation, expedited pathway applications).
- Develop regulatory project plans for assigned portfolio.
- Serve on/lead the Global Regulatory Team; act as regulatory representative on product subteams/core teams.
- Coordinate timely responses to regulatory authority questions.
- Liaise with internal departments, CROs, and regulatory program managers at Health Authorities.
- Maintain regulatory files per internal requirements.
- Oversee/ensure review of technical regulatory documentation; recommend documentation/process (SOP) changes.
- Provide EU regulatory intelligence as appropriate.
Qualifications:
- Bachelor’s degree; 6+ years in Regulatory Affairs (minimum 8 years in biotech/pharmaceutical).
- Excellent written/verbal communication, negotiation, and influencing skills.
- Solid understanding of regulations and guideline interpretation; strategic, proactive issue identification and mitigation.
- Experience with US regulatory filings and leading interactions with FDA.
- Strong organizational/project management; ability to prioritize multiple projects.
- Teamwork/interpersonal skills with internal teams and CROs.
- Technical system skills for submission-ready formatting.
Benefits: Eligible for annual short-term incentive and annual long-term incentive; comprehensive benefits include medical/dental/vision, life/disability, reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, recharge breaks, and family resources.
U.S. Pay Range: $170,900.00–$231,300.00.