Global Regulatory Strategy Director

Enveda; 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

Recharge break

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory leadership

Negotiation with authorities

Oral and written communication

Organizational awareness

Strategic thinking

Self-starter / entrepreneurial spirit

Educación

Bachelor's degree in a scientific discipline

MS/PharmD/PhD preferred

Descripción del empleo

Let's build the future of medicine - together.

Remote | Full-Time | $220,000 - $250,000

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, 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

We hire for trajectory, not just credentials. If you meet most of the above and care deeply about this problem, we want to hear from you.

ABOUT ENVEDA

We're a clinical-stage, AI-enabled biotech discovering medicines from nature four times faster than the industry standard. We recently raised $311M in a Series E, bringing total funding to over $845M, and doubled our valuation to $2B. We now have three oral medicines in the clinic, including our lead drug, ENV-294, in Phase 2 trials for eczema and asthma. Forbes named us one of America's Best Startup Employers, and Newsweek recognized us as a Top 100 Most Loved Workplace. We're still early, and most of the best work is ahead of us.

Benefits (Starting Day 1):

• Medical, dental, and vision covered at 90%
• 401(k) with company match
• Flexible PTO and a company-wide weeklong recharge break
• Adoption assistance

Our Process

We move fast and respect your time. Typically: recruiter screen - hiring manager conversation - work sample, technical interview, & culture interview.

Our Values

• Curiosity
• Agency
• Journey
• Charity
• Unity

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.