Global VP, Regulatory Strategy & Compliance

Prelude Therapeutics Incorporated; Wilmington, Northern (DE, KY); Hybrid; USD 200,000 - 320,000; Full time

Job summary

Prelude Therapeutics Incorporated seeks a visionary Vice President, Regulatory Affairs to lead regulatory strategy and oversee the regulatory affairs team. You will direct strategies, submission plans, and ensure compliance across preclinical and clinical development while coordinating with health authorities globally.

You will guide cross-functional groups, prepare for FDA and other health authority meetings, and drive risk assessment and mitigation strategies across the regulatory function at

Qualifications

• PhD or master's degree with relevant experience.
• 15+ years of regulatory affairs experience in product development and post licensure settings.
• Knowledge of global regulations/guidances and drug development processes including CMC, clinical and non-clinical aspects.

Responsibilities

• Manage a team of regulatory professionals to develop and execute Prelude’s regulatory strategy
• Provide regulatory guidance to cross-functional groups regarding preclinical and clinical development and testing
• Direct efforts for planning and execution of required regulatory filings
• Interact with FDA and other health authorities; prepare for meetings
• Ensure oversight of RA department interface with regulatory bodies
• Represent regulatory affairs on leadership and cross-functional teams
• Communicate regulatory risk assessment to senior management and propose mitigations
• Review documentation supporting regulatory applications (INDs, NDAs, BLAs, MAAs, Variations, etc.)
• Stay current with global regulatory requirements and interact with partners/consultants as needed
• Contribute regulatory perspective on government proposals and external due diligence

Education

PhD or master's degree w/ equivalent relevant experience

Job description

Prelude Therapeutics Incorporated seeks a visionary Vice President, Regulatory Affairs to lead regulatory strategy and oversee the regulatory affairs team. You will direct strategies, submission plans, and ensure compliance across preclinical and clinical development while coordinating with health authorities globally.

You will guide cross-functional groups, prepare for FDA and other health authority meetings, and drive risk assessment and mitigation strategies across the regulatory function at