Global Regulatory Strategy Director — Remote, High Impact

Enveda; United States; Remote; USD 220,000 - 250,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Flexible PTO

Recharge break

Job summary

Enveda is seeking a Global Regulatory Strategy Director to lead regulatory strategies for our small-molecule pipeline. You will partner with global project teams, manage agency interactions, and shape registrational plans across phases 2 and beyond.

This remote, full-time role offers high impact, collaboration with top scientists, and opportunities to drive submissions (INDs, NDAs) while mentoring regulatory teams and developing AI-enabled dossier strategies.

Qualifications

• Bachelor's degree in a scientific discipline; MS/PhD preferred.
• 12+ years of Regulatory Affairs experience in pharma/biotech across development.
• Strong negotiation skills with health authorities and multiple IND/CTx to NDA experience.

Responsibilities

• Provide regulatory leadership through Phase 2 and beyond and lead global registrational strategies.
• Develop innovative global regulatory strategies for clinical development and lifecycle management.
• Lead development of regulatory submissions (INDs, NDA, DMF, etc.) and manage gaps/risk.
• Represent Enveda with global health authorities and lead agency interactions.
• Guide cross-functional teams with regulatory guidance and oversight.
• Ensure regulatory activities comply with requirements and maintain HA reporting schedules.
• Stay updated on regulatory landscape and inform leadership of implications.
• Lead global regulatory teams and mentor colleagues; support senior leadership as needed.
• Develop Regulatory Affairs policies and SOPs; guide AI dossier strategies.

Skills

Regulatory leadership

Negotiation with authorities

Oral and written communication

Organizational awareness

Strategic thinking

Self-starter / entrepreneurial spirit

Education

Bachelor's degree in a scientific discipline

MS/PharmD/PhD preferred

Job description

Enveda is seeking a Global Regulatory Strategy Director to lead regulatory strategies for our small-molecule pipeline. You will partner with global project teams, manage agency interactions, and shape registrational plans across phases 2 and beyond.

This remote, full-time role offers high impact, collaboration with top scientists, and opportunities to drive submissions (INDs, NDAs) while mentoring regulatory teams and developing AI-enabled dossier strategies.