Enveda

Natural-product drug discovery platform leveraging ML

Global Regulatory Strategy Director

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeRemote in USA$220k - $250kRemote

About the Job

Requirements

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

Responsibilities

Provide regulatory leadership for company assets through Phase 2 and beyond, and lead development of global registrational strategies.
Develop innovative global regulatory strategies for the portfolio in clinical development and life-cycle management with minimal supervision.
Lead development of regulatory submissions, including INDs, CTx, briefing documents, IB, NDA, DMF, IMPD, and others; identify gaps and develop risk mitigation strategies.
Represent the company with global health authorities and lead agency interactions to achieve company objectives.
Represent Regulatory Affairs as the subject matter expert on cross-functional teams, providing regulatory guidance and oversight to global project teams.
Ensure regulatory activities comply with health authority requirements, and coordinate and maintain health authority reporting schedules with cross-functional teams.
Monitor the regulatory landscape and inform leadership about health authority initiatives and their impact on company programs.
Lead global regulatory teams, mentor and develop regulatory colleagues, and support Regulatory Affairs senior leadership as needed.
Lead development of Regulatory Affairs policies, standard operating procedures, and work instructions, and guide cross-functional teams on artificial intelligence implementation for regulatory dossiers.

Desired Qualifications

Experience across all phases of development is highly preferred.
Experience in obesity or dermatology is strongly preferred.

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: a recruiter screen → hiring manager conversation → work sample, technical interview, & culture interview.

Our Values: Curiosity | Agency | Journey | Charity | Unity

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Enveda is protecting Job Seekers

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.

If something feels off or you’re unsure whether a message is truly from Enveda, please reach out at anytime at [email protected].

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.

About the Company

Enveda

Natural-product drug discovery platform leveraging ML

Enveda Biosciences uses machine learning, metabolomics, and robotics to explore the largely untapped natural world for drug discovery. Its main asset is a proprietary high-throughput platform that runs many experiments to generate a comprehensive dataset of small molecules, including their chemical structures, biological activity, and how they distribute in organs. This data helps identify potential drug leads quickly and supports partnerships with healthcare and pharmaceutical companies through collaborations and licensing of discoveries. Unlike many rivals, Enveda focuses on expanding knowledge of natural product chemistry beyond the small portion already known, aiming to accelerate the pace of drug discovery by systematically exploring natural chemical space and building a pipeline for its partners.

Company size: 201-500
Company stage: Series D
Total funding: $534.8M
Headquarters: Boulder, CO
Founded: 2019

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