CNS Regulatory Strategy Lead — US/Global

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 170,900 - 231,300; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision coverage

401(k) with company match

Paid time off and wellness days

Job summary

Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US.

Applicants should have a Bachelor's degree and over 6 years of experience in Regulatory Affairs within the biotech or pharmaceutical industry. Strong communication skills and experience with US regulatory filings are essential.

Qualifications

• 6+ years in a Regulatory Affairs role in biotech or pharmaceuticals.
• Ability to negotiate and influence effectively.
• Experience leading interactions with US FDA.

Responsibilities

• Lead regulatory strategy for early/mid/late-stage CNS programs.
• Compile and submit regulatory documents timely.
• Coordinate responses to regulatory authorities' questions.

Skills

Communication skills

Project management

Regulatory expertise

Strategic thinking

Technical system skills

Education

Bachelor's degree

Job description

Alnylam Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Strategy in Cambridge, Massachusetts. The role involves leading regulatory strategy for CNS programs and facilitating timely submission of regulatory documents to the US.

Applicants should have a Bachelor's degree and over 6 years of experience in Regulatory Affairs within the biotech or pharmaceutical industry. Strong communication skills and experience with US regulatory filings are essential.