Associate Director, Regulatory Strategy – US Lead

Regulatory Jobs; Cambridge (MA); Hybrid; USD 171,000 - 231,000; Full time

Job summary

Alnylam seeks an Associate Director of Regulatory Affairs Strategy to lead regulatory strategy for early programs, coordinate submissions, and oversee US interactions with health authorities.

The role requires cross-functional collaboration, multidisciplinary team involvement, and regulatory intelligence sharing, with hybrid onsite presence two days per week in Cambridge, MA or Philadelphia, PA.

Qualifications

• Bachelor's degree with 6+ years in Regulatory Affairs, biotech/pharma experience 8+ years.
• Excellent written and verbal communication, negotiation and influencing skills.
• Strong understanding of regulations and guideline interpretation.
• Experience with electronic submissions (INDs, CTAs, safety reports).

Responsibilities

• Serve as US Regional Lead for assigned program and lead the Global Regulatory Team.
• Define regulatory strategy and lead preparation of regulatory documents.
• Coordinate US FDA interactions and ensure timely submissions.
• Maintain regulatory files and ensure compliance with SOPs.
• Provide regulatory intelligence to internal stakeholders.
• Collaborate with CROs and external consultants.

Skills

Regulatory strategy

Regulatory filings

IND/CTA submissions

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor's degree in Regulatory Affairs

Tools

eCTD submissions

Job description

Alnylam seeks an Associate Director of Regulatory Affairs Strategy to lead regulatory strategy for early programs, coordinate submissions, and oversee US interactions with health authorities.

The role requires cross-functional collaboration, multidisciplinary team involvement, and regulatory intelligence sharing, with hybrid onsite presence two days per week in Cambridge, MA or Philadelphia, PA.