What are the responsibilities and job description for the Senior Director Regulatory Affairs position at Vivid Resourcing?
Senior Director, Regulatory Affairs (RNA Therapeutics)
Location: Boston, MA (Hybrid – minimum 2 days per week on-site)
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.
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
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.
If this is something you're interested in, please apply directly or reach me on the following details if you require further information:
joel.isaac@vividresourcing.com
1 (980) 222 2267