Sr. Regulatory Strategy Lead, US Regional

Alnylam Pharmaceuticals, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Alnylam Pharmaceuticals, Inc. is seeking an Associate Director of Regulatory Affairs Strategy to define the regulatory strategy for assigned programs and coordinate data package submissions to the US FDA and international health authorities.

The role will also serve as the US Regional Lead for early programs and guide regulatory strategy across product development teams. The successful candidate will coordinate regulatory submissions, lead team discussions, and provide strategic regulatory

Qualifications

• Bachelor's degree with 6+ years of Regulatory Affairs experience; 8+ years in biotech/pharma.
• Excellent written and verbal communication, including negotiation and influencing.
• Solid understanding of regulations and interpretation of guidelines.
• Strategic thinking with proactive issue mitigation in drug development.
• Experience with regulatory filings including electronic submissions (INDs, CTAs, safety reporting).
• Strong organizational and project management skills; ability to prioritize multiple projects.
• Team player with ability to collaborate with CROs and internal departments.

Responsibilities

• Lead and define regulatory strategy for assigned programs and compile/submit regulatory documents per requirements.
• Lead US HA interactions and coordinate responses to questions within deadlines.
• Develop detailed regulatory project plans and support regulatory activities for portfolio.
• Represent regulatory on multidisciplinary product subteams and leadership teams.
• Provide strategic regulatory advice to project teams and maintain regulatory intelligence.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Project management

Stakeholder influence

Written and verbal communication

Education

Bachelor's degree in Science/Regulatory Affairs

Tools

eCTD preparation

Job description

Alnylam Pharmaceuticals, Inc. is seeking an Associate Director of Regulatory Affairs Strategy to define the regulatory strategy for assigned programs and coordinate data package submissions to the US FDA and international health authorities.

The role will also serve as the US Regional Lead for early programs and guide regulatory strategy across product development teams. The successful candidate will coordinate regulatory submissions, lead team discussions, and provide strategic regulatory