Associate Director Regulatory Affairs

Barrington James; San Francisco (CA); Hybrid; USD 190,000 - 240,000; Full time

Job summary

A leading life science recruitment firm seeks an Associate Director of Regulatory Affairs to lead regulatory strategies for clinical programs. This role requires collaboration with cross-functional teams to ensure compliance with global health authorities, focusing on FDA submissions. Ideal candidates have extensive experience in regulatory affairs and strong leadership skills.

Benefits

Medical insurance

Vision insurance

401(k)

Pension plan

Child care support

Paid maternity leave

Paid paternity leave

Disability insurance

Qualifications

• 8–12 years of regulatory affairs experience within biotech or pharmaceutical industry.
• Proven expertise in regulatory strategy and submission management.

Responsibilities

• Drive global regulatory strategy and implementation for clinical-stage programs.
• Act as the primary regulatory representative for assigned programs.

Skills

Leadership

Communication

Education

Bachelor’s degree in life sciences

PhD, PharmD, or MS

Job description

1 week ago Be among the first 25 applicants

This range is provided by Barrington James. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$190,000.00/yr - $240,000.00/yr

Direct message the job poster from Barrington James

Regulatory Affairs, Quality Assurance and CMC - Barrington James Life Science Recruitment US Team

Associate Director Regulatory Affairs

The Associate Director, Regulatory Affairs (Clinical Reg Focused) will lead the development and execution of regulatory strategies to support clinical programs across various stages of development. This role partners cross-functionally with clinical, nonclinical, CMC, and program management teams to ensure efficient and compliant regulatory submissions to global health authorities, with a primary focus on the FDA. It is a strategic and hands-on position ideal for a regulatory leader who thrives in a collaborative, fast-paced environment.

This position provides an exciting opportunity for an established Associate Director of Regulatory Affairs or a Strong Senior Manager ready for a step up.

Responsibilities:

• Drive global regulatory strategy and implementation for one or more clinical-stage programs.
• Act as the primary regulatory representative for assigned programs, including direct communication with the FDA and other regulatory authorities.
• Oversee and contribute to the preparation of regulatory documents such as INDs, amendments, briefing books, and orphan drug applications.
• Provide regulatory guidance and oversight to cross-functional teams regarding clinical trial protocols, study reports, and development strategy.
• Monitor and interpret changes in the regulatory landscape and assess potential impact on programs.
• Coordinate and lead regulatory interactions, including meeting preparation and participation.
• Manage external regulatory consultants and vendors, as needed.

Qualifications:

• Bachelor’s degree in life sciences; advanced degree (PhD, PharmD, or MS) preferred.
• 8–12 years of regulatory affairs experience within the biotech or pharmaceutical industry.
• Proven expertise in regulatory strategy and submission management for clinical-stage programs, particularly in the U.S.
• Experience interfacing with the FDA and contributing to IND strategy and execution.
• Strong cross-functional leadership skills and ability to work in a dynamic environment.
• Excellent written and verbal communication skills.

If you are interested in finding out more please Easy Apply with your updated resume or email me on [e-mail] or call me on 919-647-9154

Notes:

• 2/3 Days hybrid
• Relocation assistance can be provided should you want to relocate to California
• Sponsorship can be considered

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

Referrals increase your chances of interviewing at Barrington James by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Pension plan

Child care support

Paid maternity leave

Paid paternity leave

Disability insurance

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