VP of Regulatory Strategy & Global Compliance

Prelude-Therapeutics-Incorporated; Wilmington (DE); Presencial; USD 250.000 - 360.000; Jornada completa

Descripción de la vacante

Prelude-Therapeutics-Incorporated seeks a VP of Regulatory Affairs to lead regulatory strategy and team activities across development programs. You will guide cross-functional groups in preclinical and clinical development, and manage interactions with the FDA and global health authorities.

You will shape submission plans, ensure compliance with evolving regulations, and drive strategic regulatory direction for products in development and post-licensure settings.

Formación

• PhD or Master’s degree w/ equivalent relevant experience required.
• 15+ years of industry experience in Regulatory Affairs for products in development and post licensure settings.
• Strong knowledge of global regulations, drug development processes and regulatory guidance.
• Excellent written and oral communication, strategic thinking and diplomatic skills.
• Experience with international regulatory submissions strongly preferred, knowledge of Chinese regulations a plus.

Responsabilidades

• Provide leadership to develop and execute Prelude’s regulatory strategy.
• Oversee regulatory guidance to cross-functional groups for preclinical, clinical development and testing.
• Direct planning and execution of regulatory filings (INDs, NDAs, BLAs, MAAs, variations).
• Interact with FDA and other health authorities, prepare meetings and communicate risk mitigation.
• Maintain knowledge of global regulatory environment and evolving guidances.
• Represent regulatory affairs on leadership and cross-functional teams.

Conocimientos

Regulatory strategy

Global regulations

CMC knowledge

Technical writing

Cross-functional leadership

FDA/Health authority meetings

Educación

PhD or Master’s degree w/ equivalent experience

Descripción del empleo

Prelude-Therapeutics-Incorporated seeks a VP of Regulatory Affairs to lead regulatory strategy and team activities across development programs. You will guide cross-functional groups in preclinical and clinical development, and manage interactions with the FDA and global health authorities.

You will shape submission plans, ensure compliance with evolving regulations, and drive strategic regulatory direction for products in development and post-licensure settings.