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

At Enveda, we’re building a place where everyone can do the best work of their life. We are an equal opportunity employer and value diversity in all its forms. Apply now and join a team committed to shaping the future of drug discovery.