Job Title: Director Global Regulatory Affairs

Work Location: Suffolk County, Massachusetts

Summary:

This role is responsible for leading regulatory strategy and execution for assigned clinical programs, ensuring timely and effective regulatory submissions, and supporting global study milestones. The position involves authoring key regulatory documents, mapping regulatory pathways, and collaborating with cross-functional teams to drive regulatory processes forward.

Responsibilities:

• Lead planning and execution of IND/CTA filings for assigned clinical programs.
• Develop and implement regulatory strategies to support global clinical study timelines.
• Serve as primary author and strategist for essential regulatory and clinical documents.
• Identify and map regulatory pathways, including special designations and pediatric plans.
• Coordinate and lead cross-functional teams in preparation for health authority interactions.
• Conduct regulatory gap analyses and oversee the preparation and execution of regulatory filings.
• Establish strong relationships with program teams and build expertise in relevant disease areas and modalities.
• Formulate long-term regulatory strategies and identify opportunities for expedited regulatory pathways.

Qualifications:

• 8+ years of regulatory experience, including at least 2–3 years at the Associate Director level or 1–2 years at the Director level or higher.
• Proven experience leading global regulatory submission strategies and filings (IND and/or CTAs) with major health authorities (e.g., FDA, EMA, MHRA).
• Direct experience preparing meeting packages and supporting agency interactions.
• Primary author and strategist for regulatory designations such as orphan drug, fast track, or breakthrough status.
• Experience with health authority interactions and briefing book authoring.
• Flexible, adaptive, collaborative, and able to independently drive regulatory processes.
• Preferred: Experience in cardiac or muscular dystrophy disease areas.
• Preferred: Experience with siRNA or antisense oligonucleotide (ASO) therapies.
• Bachelor's degree or higher.

Published Category: Regulatory Affairs