Associate Director Regulatory Affairs

HireMinds; United States; On-site; USD 170,000 - 220,000; Full time

Job summary

A leading biotech company is seeking a Regulatory Strategist to guide regulatory efforts in advanced therapeutics. The role involves developing regulatory strategies for biologics, managing cross-functional teams, and collaborating closely on submissions. Ideal candidates will have extensive experience in the field, including leadership roles and knowledge of regulatory compliance.

Qualifications

• Minimum 8+ years in regulatory affairs for biologics/pharmaceuticals.
• Experience with IND submissions via ESG.
• In-depth knowledge of FDA regulations (21 CFR 1271, 312).

Responsibilities

• Lead regulatory strategy for biologics, including IND submissions.
• Manage cross-functional team alignment and compliance.
• Contribute to long-term regulatory planning.

Skills

Cross-functional communication

Regulatory strategy

Team leadership

Data-driven insights

Education

Bachelor’s Degree

Higher education preferred

Tools

eCTD format

Job description

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

Base pay range

$170,000.00/yr - $220,000.00/yr

Regulatory Strategist – Advanced Therapeutics (Associate Director)

Our biotech client is pioneering next-generation regenerative medicine and seeking a Regulatory Expert to lead efforts in defining and executing regulatory strategy for a cutting-edge tissue engineering program. This is an opportunity to join a mission-driven, collaborative, and scientifically rigorous team dedicated to transforming the future of transplantation and therapeutic development.

Key Responsibilities:

• Lead regulatory strategy for complex biologics, including preparation and execution of IND submissions
• Manage timelines, documentation, and communication across cross-functional teams to ensure alignment and compliance
• Collaborate closely with scientific, clinical, and quality teams to support regulatory submissions in eCTD format via the ESG
• Guide long-term regulatory planning, contributing to the broader clinical and commercial strategy

Minimum Qualifications:

• Bachelor’s Degree, minimum (higher education preferred!)
• 8+ years of industry regulatory affairs experience in biologics or pharmaceuticals
• 8+ years of project or team leadership experience
• Direct experience writing and submitting INDs via the ESG in eCTD format
• Demonstrated success in leading regulatory submissions and influencing strategy through data-driven insights
• Excellent cross-functional communication and collaboration skills in hybrid or remote settings
• Experience mentoring and guiding team members at various levels
• In-depth knowledge of FDA regulations, particularly 21 CFR 1271 and 21 CFR 312.

This is a rare chance to shape regulatory direction at the forefront of biotech innovation. If you’re motivated by science, impact, and working with exceptional people, don't hesitate to apply!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Strategy/Planning and Other

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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