Global Regulatory Strategy Lead

Contraline, Inc.; Charlottesville (VA); On-site; USD 210,000 - 320,000; Full time

Job summary

Contraline, Inc. is seeking a senior regulatory leader to develop and execute global regulatory strategies across its growing pipeline of therapeutics and devices, guiding INDs, NDAs, and regulatory submissions in collaboration with cross-functional teams.

The role requires an advanced scientific degree and 15+ years of regulatory affairs experience, with demonstrated FDA interactions and major submissions.

Qualifications

• 15+ years of regulatory affairs experience in pharma/biotech
• Experience leading FDA interactions and major submissions (including 505(b)(2))
• Proven success obtaining IND clearances and advancing programs
• Ability to operate in entrepreneurial, resource-constrained environments

Responsibilities

• Develop and execute global regulatory strategies
• Lead regulatory interactions with FDA and other authorities
• Oversee preparation and submission of INDs, NDAs, BLAs, and global filings
• Build and scale the regulatory affairs function as the company grows
• Collaborate with Clinical Development, CMC, Quality, Nonclinical, Medical Affairs, and external partners
• Evaluate regulatory risks and mitigate proactively
• Support diligence activities related to partnerships and acquisitions

Skills

Regulatory leadership

FDA interactions

Regulatory strategy

Cross-functional collaboration

Stakeholder management

Education

PhD/MD/PharmD (relevant field)

Regulatory Affairs Certification (RAC)

Job description

Contraline, Inc. is seeking a senior regulatory leader to develop and execute global regulatory strategies across its growing pipeline of therapeutics and devices, guiding INDs, NDAs, and regulatory submissions in collaboration with cross-functional teams.

The role requires an advanced scientific degree and 15+ years of regulatory affairs experience, with demonstrated FDA interactions and major submissions.