Global Regulatory Strategy Director

Let’s build the future of medicine - together.

YOUR ROLE

As a Global Regulatory Strategy Director at Enveda, you'll lead the development and execution of innovative regulatory strategies for our pipeline of first-in-class small-molecule medicines. You'll partner with global project teams as the regulatory subject matter expert and lead Enveda's interactions with health authorities worldwide. In your first year, you'll shape our global registrational strategies and lead the submissions that support them. This is a high impact opportunity where you'll influence our global regulatory strategy and small-molecule clinical pipeline while collaborating with some of the brightest minds in the industry.

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), 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

• A 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
• A strong understanding of regulatory operational activities
• Self-starter with an entrepreneurial spirit, flexible and proactive in adapting to changing business needs and priorities
• A pragmatic, compliant, solution-oriented mindset