Remote Global Regulatory Strategy Director

Amino Collective; 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

Adoption assistance

Descripción de la vacante

Enveda is seeking a Global Regulatory Strategy Director to lead regulatory strategies across a pipeline of small-molecule medicines. You will partner with global project teams as the regulatory SME and steer interactions with health authorities worldwide, shaping registrational strategies and submissions in the first year.

You will guide regulatory submissions (INDs, CTX, NDA, DMF, IMPD, etc.), mentor regulatory teams, and stay ahead of regulatory trends to support Enveda's clinical programs.

Formación

• Bachelor's degree in a scientific discipline is required.
• MS/PhD/PharmD preferred for leadership in regulatory strategy.

Responsabilidades

• Provide regulatory leadership through Phase 2 and beyond and lead global registrational strategies.
• Develop innovative global regulatory strategies for portfolio in clinical development and lifecycle management.
• Lead the development of regulatory submissions (INDs, NDA, etc) and regulatory documentation.
• Represent regulatory affairs with global health authorities and lead agency interactions.
• Serve as subject-matter expert to cross-functional teams and provide regulatory guidance.
• Ensure regulatory activities comply with health authority requirements and HA reporting schedules.
• Keep leadership informed of regulatory landscape and health authority initiatives.
• Lead global regulatory teams, mentor colleagues, and support regulatory leadership.
• Develop regulatory policies, SOPs, and guide AI-enabled dossiers.

Conocimientos

Regulatory leadership

Cross-functional collaboration

Strategic planning

Communication skills

Regulatory submissions

Educación

Bachelor's degree in scientific field

MS/PharmD/PhD preferred

Descripción del empleo

Enveda is seeking a Global Regulatory Strategy Director to lead regulatory strategies across a pipeline of small-molecule medicines. You will partner with global project teams as the regulatory SME and steer interactions with health authorities worldwide, shaping registrational strategies and submissions in the first year.

You will guide regulatory submissions (INDs, CTX, NDA, DMF, IMPD, etc.), mentor regulatory teams, and stay ahead of regulatory trends to support Enveda's clinical programs.