Senior Director, Regulatory Affairs (RNA Therapeutics)
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:
#J-18808-Ljbffr
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:
#J-18808-Ljbffr