Remote Global Regulatory Strategy Director - First-in-Class Meds

dimensioncap.com; United States; A distancia; USD 220.000 - 250.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision coverage

401(k) with company match

Flexible PTO & recharge break

Adoption assistance

Descripción de la vacante

Enveda is seeking a Global Regulatory Strategy Director to lead regulatory strategies for small-molecule medicines. You will partner with global teams as the regulatory SME and steer submissions with health authorities worldwide.

This leadership role focuses on registrational strategy and lifecycle management across development stages. You will mentor Regulatory Affairs colleagues, shape policies, and guide cross-functional teams on AI-enabled regulatory dossiers.

Formación

• Bachelor level degree in science; advanced degree preferred for leadership roles.
• Extensive Regulatory Affairs experience across development phases (IND/CTx to NDA).
• Experience interacting with health authorities (FDA, EMA, etc.) and leading global submissions.

Responsabilidades

• Provide regulatory leadership for assets through Phase 2 and beyond.
• Develop global regulatory strategies for clinical development and lifecycle management.
• Lead development of regulatory submissions (INDs, CTX, NDA, DMF, IMPD).
• Represent Enveda with global health authorities and lead agency interactions.
• Guide cross-functional teams with regulatory guidance and oversight.

Conocimientos

Regulatory leadership

Stakeholder management

Regulatory strategy

IND/CTx submissions

Leadership & mentoring

Regulatory operations

Entrepreneurial mindset

Educación

Bachelor's degree in a scientific discipline

Advanced degree (MS, PharmD, or PhD) preferred

Descripción del empleo

Enveda is seeking a Global Regulatory Strategy Director to lead regulatory strategies for small-molecule medicines. You will partner with global teams as the regulatory SME and steer submissions with health authorities worldwide.

This leadership role focuses on registrational strategy and lifecycle management across development stages. You will mentor Regulatory Affairs colleagues, shape policies, and guide cross-functional teams on AI-enabled regulatory dossiers.