Global Regulatory Strategy Director

United StatesRemoteFull-timeexecutive

Legal & ComplianceRegulatory

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Quick Summary

Overview

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,

Technical Tools

Legal & ComplianceRegulatory

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.

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

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.

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.

What We Offer

~1 min read

We care deeply about creating a safe, respectful experience for every applicant, so we wanted to share a few guidelines to help you spot anything that doesn’t feel right.

✓You’ll always meet real Enveda team members through video or in-person conversations before receiving an offer.

✓All communication from us will come from an @enveda.com or @envedabio.com email address.

✓We’ll never ask you to purchase equipment, send money, or share sensitive banking details as part of any step in our recruiting process.

Location & Eligibility

Where is the job

United States

Remote within one country

Who can apply

About this job

Pay per year: $220,000–$250,000 a year; 41% above the $166,400 median for Regulatory jobs on Jobera (235 salaries).
Who can apply: United States
Posted: Today
Employer: has 12 open jobs on Jobera in 2 countries.