Global Regulatory Strategy Director
At Enveda · Remote, United States
- Operations
- Full-time
- Director or above
See how well you match Match me reads your CV and picks the jobs that suit you best.
Get jobs like this within hours Radar emails you new jobs open to you within hours of us finding them, before most people see them.
Where you can work from
Open to the United States
“Remote, United States”
From the location.
Report a mistake
- Posted
- 6 November 2026
- First seen by us
- 7 November 2026
- Last checked
- 2 hours ago
Job description
From Enveda’s job post, as they wrote it.
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
Read the full description
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.
Global Regulatory Strategy DirectorEnveda
Apply on Enveda (opens in a new tab)Get jobs like this by email
Once a week, we email the new remote jobs open where you live, each with the line that proves it. Every email has a one-click unsubscribe.
