Global Regulatory Strategy Director

WHAT YOU'LL DO

• Provide regulatory leadership for Enveda's assets through Phase 2 and beyond, and lead the development of global registrational strategies
• With minimal supervision, develop innovative global regulatory strategies for Enveda's portfolio in clinical development and life-cycle management
• Lead the development of regulatory submissions (INDs, CTx, briefing documents, IB, NDA, DMF, IMPD, and more), identifying gaps and developing risk mitigation strategies
• Represent Enveda with global health authorities and lead agency interactions to achieve company objectives
• Represent Regulatory Affairs on cross-functional teams as the subject matter expert, providing regulatory guidance and oversight to global project teams
• Ensure Enveda's regulatory activities comply with health authority requirements, and coordinate and maintain all HA reporting schedules with cross-functional teams
• Stay on top of the regulatory landscape and keep leadership informed of health authority initiatives and their impact on Enveda's programs
• Lead the global regulatory team(s), mentor and develop regulatory colleagues, and support Regulatory Affairs senior leadership as needed
• Lead the development of Regulatory Affairs policies, SOPs, and work instructions, and guide cross-functional teams on AI implementation for regulatory dossiers

WHAT WE'RE LOOKING FOR

• Bachelor's degree in a scientific discipline; an advanced degree (MS, PharmD, or PhD) is preferred
• At least 12 years of Regulatory Affairs experience in pharma or biotech; experience across all phases of development is highly preferred
• Strong negotiation skills with health authorities (e.g., FDA, EMA, Health Canada), plus submission experience from IND/CTx through NDA or marketing applications
• Experience developing and executing regulatory strategies for oral small-molecule programs, and experience in obesity or dermatology, both strongly preferred
• Excellent oral, written, and presentation skills, including experience presenting to leadership teams
• Demonstrated organizational awareness, including experience representing Regulatory Affairs cross-functionally and on global teams
• Excellent planning and organizational skills, with the ability to work on multiple projects with tight timelines in a fast-paced, hands-on environment
• Strong understanding of regulatory operational activities
• Self-starter with an entrepreneurial spirit, flexible and proactive in adapting to changing business needs and priorities
• Pragmatic, compliant, solution-oriented mindset