Associate Director, Regulatory Affairs
Alnylam Pharmaceuticals
August 20, 2026
Remote friendly (Philadelphia, PA)
United States
Corporate Functions
Associate Director of Regulatory Affairs Strategy (Hybrid)
Summary of Key Responsibilities
- Serve as US Regional Lead or Global Regulatory Lead for early/mid/late-stage CNS programs.
- Lead and define regulatory strategy; compile and submit regulatory documents and lead US Health Authority (HA) interactions (e.g., INDs, meeting requests/briefing documents, Marketing Applications, Pediatric Plans, Orphan Designation, Expedited Pathway/Breakthrough Designation).
- Develop detailed regulatory project plans and support regulatory activities for assigned portfolios.
- Participate in/lead the Global Regulatory Team and represent Regulatory Affairs on multidisciplinary product subteams.
- Coordinate timely responses to regulatory authority questions within deadlines.
- Liaison with internal departments, CROs, and regulatory program managers at HAs.
- Maintain regulatory files per internal requirements.
- Review technical regulatory documentation and recommend changes to documentation/processes, including SOPs for compliance.
- Provide EU-specific regulatory intelligence as appropriate.
Qualifications
- Bachelor’s degree with 6+ years in Regulatory Affairs (minimum 8 years biotech/pharma industry experience).
- Excellent written/verbal communication; negotiation and influencing skills.
- Solid understanding of regulations and experience interpreting guidelines.
- Strategic thinking; proactive issue identification and mitigation.
- Experience with US regulatory filings and leading US FDA interactions.
- Strong organizational/project management; ability to prioritize multiple projects.
- Team-oriented with strong interpersonal skills.
- Technical system skills (e.g., word processing, spreadsheets, databases, online research) including submission-ready formatting.
- Alignment with core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, Passion for Excellence.
Benefits / Compensation (as stated)
- US pay range: $170,900.00–$231,300.00; eligible for annual short-term incentive and annual long-term incentive.
- Comprehensive benefits include medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, and 401(k) match; PTO, wellness days, holidays, recharge breaks, and family leave/resources.
Summary of Key Responsibilities
- Serve as US Regional Lead or Global Regulatory Lead for early/mid/late-stage CNS programs.
- Lead and define regulatory strategy; compile and submit regulatory documents and lead US Health Authority (HA) interactions (e.g., INDs, meeting requests/briefing documents, Marketing Applications, Pediatric Plans, Orphan Designation, Expedited Pathway/Breakthrough Designation).
- Develop detailed regulatory project plans and support regulatory activities for assigned portfolios.
- Participate in/lead the Global Regulatory Team and represent Regulatory Affairs on multidisciplinary product subteams.
- Coordinate timely responses to regulatory authority questions within deadlines.
- Liaison with internal departments, CROs, and regulatory program managers at HAs.
- Maintain regulatory files per internal requirements.
- Review technical regulatory documentation and recommend changes to documentation/processes, including SOPs for compliance.
- Provide EU-specific regulatory intelligence as appropriate.
Qualifications
- Bachelor’s degree with 6+ years in Regulatory Affairs (minimum 8 years biotech/pharma industry experience).
- Excellent written/verbal communication; negotiation and influencing skills.
- Solid understanding of regulations and experience interpreting guidelines.
- Strategic thinking; proactive issue identification and mitigation.
- Experience with US regulatory filings and leading US FDA interactions.
- Strong organizational/project management; ability to prioritize multiple projects.
- Team-oriented with strong interpersonal skills.
- Technical system skills (e.g., word processing, spreadsheets, databases, online research) including submission-ready formatting.
- Alignment with core values: Commitment to People, Fiercely Innovative, Purposeful Urgency, Open Culture, Passion for Excellence.
Benefits / Compensation (as stated)
- US pay range: $170,900.00–$231,300.00; eligible for annual short-term incentive and annual long-term incentive.
- Comprehensive benefits include medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, and 401(k) match; PTO, wellness days, holidays, recharge breaks, and family leave/resources.