VP, Regulatory Affairs & Quality — Lead Novel Biologics

Slate Medicines; Raleigh (NC); On-site; USD 250,000 - 420,000; Full time

Job summary

Slate Medicines is seeking a VP, Regulatory Affairs & Quality to build both functions from the ground up and serve as the primary voice with the FDA as we advance SLTE-1009 for migraine and other headache disorders.

This leadership role will own end-to-end regulatory strategy from nonclinical through BLA, shape CMC for a monoclonal antibody, establish GxP compliance and safety governance, and grow the team by hiring a Director or Senior Director, Regulatory Affairs.

Qualifications

• 12–15+ years of regulatory affairs and/or quality leadership in biotech or pharma.
• Experience guiding FDA interactions for novel mechanisms.
• Bachelor’s degree required; advanced degree strongly preferred.

Responsibilities

• Own end-to-end regulatory strategy from nonclinical through BLA.
• Lead FDA meetings and primary regulatory liaison with health authorities.
• Build CMC strategy for monoclonal antibody programs.
• Establish safety governance, GxP compliance, and quality oversight.
• Grow the function by hiring a Director/Senior Director, Regulatory Affairs.

Skills

Regulatory leadership

Biotech/pharma regulatory affairs

Quality leadership

GxP compliance

FDA interactions

Team building

Education

Bachelor's degree

Advanced degree (MS/PhD/MD/PharmD)

Job description

Slate Medicines is seeking a VP, Regulatory Affairs & Quality to build both functions from the ground up and serve as the primary voice with the FDA as we advance SLTE-1009 for migraine and other headache disorders.

This leadership role will own end-to-end regulatory strategy from nonclinical through BLA, shape CMC for a monoclonal antibody, establish GxP compliance and safety governance, and grow the team by hiring a Director or Senior Director, Regulatory Affairs.