Global VP, Regulatory Strategy - Gene Therapy

Regulatory Jobs; Cambridge (MA); Sur place; USD 313 000 - 348 000; Plein temps

Avantages offerts par ce poste

Base salary

Bonus eligibility

Equity

Benefits package

Collaborative culture

Résumé du poste

Prime Medicine is seeking a Vice President, Regulatory Affairs to shape global regulatory strategy from early development through BLA/MAA submissions. This leader will mentor a high-performing regulatory team and partner with Research, CMC, Clinical Development, and Program Management.

You will interface with FDA and EMA, manage high-stakes meetings, and drive regulatory submissions across US, EU, and other regions, ensuring timely, high-quality filings and compliance.

Qualifications

• Bachelor's degree in a scientific discipline required; and advanced degree strongly preferred.
• 15+ years of regulatory affairs experience with 5+ years in global leadership.
• Experience in gene therapy, gene editing, cell therapy, or ATMPs preferred.
• Experience with FDA/EMA and complex regulatory submissions.

Responsabilités

• Develop and own global regulatory strategies for Prime Medicine programs.
• Interface with FDA, EMA, and global authorities; lead regulatory meetings.
• Oversee IND/CTA filings and submissions (BLA/NDA/MAA).
• Lead regulatory risk assessment and cross-functional readiness.
• Mentor regulatory team and oversee CRO/CMO activities.

Connaissances

Strategic regulatory leadership

Cross-functional collaboration

Regulatory strategy development

Stakeholder communication

Formation

Bachelor's degree in a scientific discipline

Advanced degree (PhD/PharmD/MD) preferred

Description du poste

Prime Medicine is seeking a Vice President, Regulatory Affairs to shape global regulatory strategy from early development through BLA/MAA submissions. This leader will mentor a high-performing regulatory team and partner with Research, CMC, Clinical Development, and Program Management.

You will interface with FDA and EMA, manage high-stakes meetings, and drive regulatory submissions across US, EU, and other regions, ensuring timely, high-quality filings and compliance.