VP of Regulatory Strategy & Compliance

Prelude Therapeutics Incorporated; Wilmington (DE); On-site; USD 180,000 - 350,000; Full time

Job summary

Prelude Therapeutics Incorporated seeks a Vice President of Regulatory Affairs to lead regulatory strategy for development and post-licensure. You will guide cross-functional teams, plan regulatory filings, and coordinate with the FDA and health authorities to secure approvals.

You will maintain a deep understanding of global regulations, drive strategic decisions, and ensure regulatory readiness across product pipelines.

Qualifications

• Requires PhD or Master’s degree or equivalent experience.
• 15+ years in Regulatory Affairs for development and post-licensure.
• Strong knowledge of global regulations and drug development processes.

Responsibilities

• Lead and oversee regulatory strategy for Prelude's products.
• Provide regulatory guidance to cross-functional teams in preclinical and clinical development.
• Direct planning and execution of regulatory filings.
• Interface with FDA and health authorities to obtain approvals.
• Prepare teams for FDA meetings and regulatory discussions.
• Communicate regulatory risk and mitigation to senior management.
• Maintain up-to-date knowledge of global regulations and guidances.

Skills

Regulatory Strategy

Global Regulations

Regulatory Submissions

Strategic Thinking

Technical Writing

CMC Knowledge

Biopharma Manufacturing

International Submissions

Education

PhD or Master’s degree

Job description

Prelude Therapeutics Incorporated seeks a Vice President of Regulatory Affairs to lead regulatory strategy for development and post-licensure. You will guide cross-functional teams, plan regulatory filings, and coordinate with the FDA and health authorities to secure approvals.

You will maintain a deep understanding of global regulations, drive strategic decisions, and ensure regulatory readiness across product pipelines.