Strategic Regulatory Affairs Director

Gateway Recruiting; San Francisco (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Gateway Recruiting is seeking an experienced Regulatory Affairs leader to manage all regulatory activities for the company, developing strategies from pre-IND to NDA. You will work with internal R&D and commercial teams and act as the primary liaison with regulatory authorities, ensuring timely, scientifically valid submissions and compliant documentation.

The role requires a Bachelor's in a scientific field and 10–12+ years in biotech/pharma regulatory affairs, familiarity with 21 CFR parts and

Qualifications

• Bachelor’s degree in scientific discipline required; advanced degree preferred.
• 10 to 12+ years of senior regulatory experience in biotech/pharma with pre-IND to NDA.
• Familiarity with 21 CFR Part 210, 211 and 820, ISO 13485, EU MDR 2017/745 and related standards.
• Experience authoring regulatory submissions (IND, NDA, Annual Reports, Supplements).

Responsibilities

• Develop and implement regulatory strategies for IND through NDA submissions.
• Collaborate with project teams to ensure regulatory compliance across development lifecycle.
• Direct regulatory activities for maintenance and continued compliance of commercial products.
• Serve as liaison to regulatory authorities.
• Coordinate partner submissions and prepare documents for sections under company responsibility.
• Act as PV/Drug Safety representative for external partners.
• Provide regulatory leadership to directs and cross-functional teams.
• Prepare regulatory submissions (IND, NDA, Technical File) coordinating cross-function data.
• Develop internal policies and strategies for submissions and risk identification.
• Review and approve submission documents for compliance.
• Maintain IND, NDA and other regulatory submission documents including tracking.
• Manage post-market filings and product safety reports.
• Provide updates to Executive Team and project teams.
• Establish and maintain regulatory SOPs.
• Regulatory surveillance to ensure compliance.
• Work with SMEs to assess impact of new regulations.

Skills

IND submissions

NDA submissions

FDA regulatory submissions

Drug safety / pharmacovigilance

Regulatory strategy

Leadership

Cross-functional collaboration

Regulatory writing

Post-market surveillance

Education

Bachelor's degree in science

10–12+ years regulatory experience

GMP knowledge

Regulatory certification

Tools

Regulatory document system

EDMS

Job description

Gateway Recruiting is seeking an experienced Regulatory Affairs leader to manage all regulatory activities for the company, developing strategies from pre-IND to NDA. You will work with internal R&D and commercial teams and act as the primary liaison with regulatory authorities, ensuring timely, scientifically valid submissions and compliant documentation.

The role requires a Bachelor's in a scientific field and 10–12+ years in biotech/pharma regulatory affairs, familiarity with 21 CFR parts and