SVP, Regulatory Affairs

Meet Life Sciences; United States; Remote; USD 180,000 - 300,000; Full time

Job summary

An exciting pre-IPO biotech firm is seeking a Senior Vice President of Regulatory Affairs to lead their first IND filing. This remote opportunity requires monthly travel to key locations. The role involves overseeing regulatory guidance for preclinical and clinical programs, ensuring compliance with regulatory requirements. The ideal candidate will have over 15 years of experience in Regulatory Affairs, particularly in cell/gene therapy, and a proven track record of leading successful regulatory submissions. Join a dynamic team that is dedicated to advancing innovative treatments for hematological conditions.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 15+ years of experience in Regulatory Affairs required.
• Experience in cell/gene therapy and leading IND/CTA through NDA/BLA/MAA.

Responsibilities

• Lead the Regulatory Affairs function and provide guidance for development programs.
• Plan and develop key regulatory submissions with cross-functional teams.

Skills

Regulatory Affairs

Cell/Gene Therapy

IND/CTA Submission

NDA/BLA/MAA Submission

Leadership

Job description

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Senior Vice President, Regulatory Affairs

*Remote Opportunity with monthly travel to Bay Area, CA or Cambridge, MA required*

Meet has partnered with an exciting, pre-IPO biotech that is developing treatments for hematological conditions utilizing an innovative cell therapy platform. They are looking for an SVP of Regulatory Affairs to join their team and lead their first IND filing.

Key Responsibilities

• You will serve as the head of the Regulatory Affairs function, providing regulatory guidance for all preclinical and clinical development programs.
• You will lead the planning and development of key regulatory submissions (IND/CTA, BLA/MAA) with cross-functional team members.

Key Qualifications

• 15+ years of Regulatory Affairs experience
• Experience in cell/gene therapy required
• Experience leading programs from IND/CTA through NDA/BLA/MAA required
• Small biotech experience highly preferred

Please reach out to Ryan Moran if you're interested in learning more:

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Strategy/Planning, Science, and Writing/Editing

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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