An innovative, clinical-stage RNA therapeutics company in the Boston biotech hub is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy across a growing pipeline of RNA-based medicines.
This role sits at the heart of the company’s clinical and CMC strategy, working directly with executive leadership to drive regulatory success from IND through late-stage development and commercialization.
About the company:
This position is Boston-based with a hybrid working policy (minimum 2 days per week on-site). The company is specifically looking for local or relocatable candidates who want to be closely connected to the executive team, scientists, and regulators.
The Opportunity:
You will own and shape the regulatory roadmap for multiple RNA programs, helping transition the company from early clinical development into pivotal trials and eventual BLA/NDA filings. This is a highly visible leadership role with direct influence on company valuation, investor confidence, and speed to market.
Key Responsibilities:
- Lead global regulatory strategy for RNA-based therapeutics (siRNA, mRNA, antisense, or related modalities)
- Serve as regulatory lead for INDs, amendments, briefing packages, and FDA interactions
- Own regulatory planning for Phase I–III clinical development and registration
- Guide CMC regulatory strategy for complex RNA manufacturing, formulation, and delivery technologies
- Act as the primary FDA, EMA, and global health authority liaison
- Lead regulatory input into labelling, lifecycle management, and post-approval commitments
- Build, mentor, and scale a high-performing Regulatory Affairs team
- Partner closely with Clinical Development, CMC, Quality, and Program Management
- Support fundraising, partnerships, and due diligence with regulatory expertise
What They’re Looking For:
- Senior-level regulatory leader with deep RNA or advanced modality experience
- Strong track record delivering INDs and late-stage regulatory submissions
- Experience working with the FDA on novel or complex therapeutic platforms
- Background across clinical, CMC, and regulatory strategy
- Prior experience in small to mid-size biotech or high-growth environments
- Comfortable operating at executive and Board level
Why This Role Stands Out:
- Direct ownership of regulatory strategy for a cutting-edge RNA platform
- Opportunity to shape first-in-class or best-in-class programs
- Strong funding position with programs moving toward pivotal trials
- High-impact leadership role reporting into the C-suite
- Hybrid model in Boston’s RNA and biotech innovation hub