Senior Director, Regulatory Affairs

Meet Life Sciences; Boston (MA); Hybrid; USD 250,000 - 295,000; Full time

Job summary

An exciting biotech company is seeking a Senior Director or Executive Director of Regulatory Affairs to lead regulatory strategies for biologic drugs. This hybrid role offers the opportunity to work closely with a robust clinical development pipeline across various therapeutic areas. The ideal candidate will have extensive experience in Regulatory Affairs, particularly with biologic products, and will play a critical role in FDA interactions and submission strategies. Join a forward-thinking organization where your expertise will significantly impact the future of healthcare.

Qualifications

• 12+ years of experience in Regulatory Affairs with a focus on biologic products.
• Proven track record managing programs from IND/CTA to BLA/MAA.

Responsibilities

• Develop regulatory strategies for biologic drugs and oversee CMC submissions.
• Act as primary contact for FDA interactions and support late-stage programs.

Skills

Regulatory Affairs

Biologic Drugs

FDA Interactions

CMC Regulatory Strategy

Job description

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This salary range is provided by Meet Life Sciences. Your actual pay will depend on your skills and experience — discuss with your recruiter to learn more.

Base pay range

$250,000.00/yr - $295,000.00/yr

Direct message the job poster from Meet Life Sciences

Senior Director or Executive Director, Regulatory Affairs

*Hybrid Role - 3x per week onsite in Waltham, MA*

Meet has partnered with an exciting biotech company seeking a Senior Director or Executive Director of Regulatory Affairs. The company has a robust clinical development pipeline with programs ranging from Phase I through Phase III, across nephrology, autoimmunity, and virology.

Key Responsibilities

• Develop and implement regulatory strategies for biologic drugs (MABs, fusion proteins, bispecific antibodies).
• Support IND/CTA-enabling studies and late-stage programs with high-level regulatory input.
• Act as the primary contact for FDA interactions.
• Lead CMC regulatory strategies, oversee Module III of CMC sections, and develop regulatory submission plans.

Key Qualifications

• 12+ years of Regulatory Affairs experience.
• Experience managing programs from IND/CTA to BLA/MAA.
• Experience with biologic products, preferably monoclonal antibodies.
• Experience in CMC regulatory strategy development.

Contact Ryan Moran to learn more about this opportunity.

Additional Details

• Seniority level: Director
• Employment type: Full-time
• Job functions: Writing/Editing, Strategy/Planning, Science
• Industries: Biotechnology Research, Pharmaceutical Manufacturing

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