--- title: 'Global Regulatory Strategy Director at Enveda' canonical: 'https://feeny.ai/job/global-regulatory-strategy-director-enveda-united-states-ktw8180xaxgp' type: 'job' last_seen: '2026-11-07' --- # Global Regulatory Strategy Director at Enveda - **Company:** Enveda - **Location:** United States - **Employment:** full-time - **Work type:** remote - **Posted:** 2026-11-06 - **Last confirmed live:** 2026-11-07 - **Apply:** https://jobs.lever.co/enveda/9804262e-f227-4986-8004-b82320b38ce7 ## Job description 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 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 Enveda ## Company Overview - **One-liner**: Enveda is a drug discovery company that uses an AI-powered platform to analyze natural molecules and accelerate the development of new medicines. - **Entity Type**: Private (Startup) - **Headquarters**: Boulder, Colorado, USA - **Founded**: 2019 - **Founders**: Not publicly available ## Core Business - **Primary industry/industries**: Biotechnology, Drug Discovery, Artificial Intelligence - **Target customers**: B2B (pharma partners) and B2C (patients via pipeline drugs); primarily a biotech R&D company - **Mission or purpose statement**: "Learning from life to bring hope to and improve the health of people everywhere." [enveda.com](https://enveda.com/) ## Products & Services - **AI Drug Discovery Platform**: A proprietary platform that combines the world’s largest library of plant-derived molecules, a foundation model for natural chemistry (PRISM), and an automated lab to identify and characterize therapeutic candidates at 4X the industry speed. [enveda.com/platform](https://enveda.com/platform/) - **Pipeline of Drug Candidates**: Three clinical-stage assets across four indications, plus six IND-enabling assets and 17 development candidates. Key programs include ENV-294 (Phase 2a for atopic dermatitis), ENV-308 (Phase 1 for metabolic health), and ENV-6946 (Phase 1 for inflammatory bowel disease). [enveda.com/pipeline](https://enveda.com/pipeline/) ## Market Standing - **Valuation/Market Cap**: Not publicly available - **Key Metric**: Total Funding – Not disclosed; however, the company has advanced multiple molecules into clinical trials, indicating significant capital. - **Notable Investors/Partners**: Not publicly available - **Growth Signals**: Ranked #2 in Life Science Startups and #26 out of 5,000 companies in America’s Best Startup Employers. [enveda.com/careers](https://enveda.com/careers/) Three clinical assets already in trials, with a growing pipeline and team. ## Competitive Advantages - **Speed**: Platform discovers candidate medicines 4X faster than the industry average. - **Scale**: World’s largest searchable library of plant-derived molecules, with over a billion mass spectra used to train the PRISM AI model. - **Integration**: Fully automated lab combined with proprietary AI that can predict molecular structures in half a second, replacing weeks of traditional analysis. ## Strategic Focus - Advance current pipeline candidates through clinical development (atopic dermatitis, metabolic health, IBD). - Expand platform applications beyond drug discovery into fields like agriculture, nutrition, and manufacturing. - Continue to grow the team and scale the platform’s capabilities. ## Why Work Here - **Culture**: Emphasizes learning, growth, and “love” as a motivator. Described as “Learners Wanted. Growth Guaranteed.” - **Work-Life Harmony**: Weeklong company break at year-end, flexible PTO, 12 weeks paid parental leave, adoption assistance, and a work-from-home stipend. - **Recognition**: Named a top startup employer (#2 in Life Science Startups). - **Location**: Office in Boulder, Colorado, with hybrid/remote flexibility (work-from-home stipend offered). ## Sources 1. [enveda.com](https://enveda.com/) 2. [enveda.com/careers](https://enveda.com/careers/) 3. [enveda.com/pipeline](https://enveda.com/pipeline/) 4. [enveda.com/platform](https://enveda.com/platform/) ## Other roles at Enveda - [Manager IT & Infrastructure](https://feeny.ai/job/manager-it-infrastructure-enveda-hyderabad-mb977dww41n0) — Hyderabad, India - [Sr. CMC Project Manager](https://feeny.ai/job/sr-cmc-project-manager-enveda-united-states-gfzgms3wdef8) — United States - [VP, Clinical Biostatistics](https://feeny.ai/job/vp-clinical-biostatistics-enveda-united-states-c8hcr8zzxmzq) — United States - [Senior Histopathologist](https://feeny.ai/job/senior-histopathologist-enveda-hyderabad-h3nv698g55t8) — Hyderabad, India - [Sr. Clinical Development Director](https://feeny.ai/job/sr-clinical-development-director-enveda-united-states-zcse1y0v8a8r) — United States - [Director, ADME](https://feeny.ai/job/director-adme-enveda-hyderabad-by4wj84grep0) — Hyderabad, India - [Assoc. Director, Medicinal Chemistry](https://feeny.ai/job/assoc-director-medicinal-chemistry-enveda-hyderabad-jv13599z0qc5) — Hyderabad, India - [Research Associate, Invivo Pharmacology](https://feeny.ai/job/research-associate-invivo-pharmacology-enveda-hyderabad-g0dfqk43a3qf) — Hyderabad, India - [Sr. ADME and Quantitative Pharmacology Director](https://feeny.ai/job/sr-adme-and-quantitative-pharmacology-director-enveda-united-states-z5k3dyehx5a6) — United States - [Senior Research Associate, Invivo Pharmacology](https://feeny.ai/job/senior-research-associate-invivo-pharmacology-enveda-hyderabad-qqtzhempmtgg) — Hyderabad, India