Global Regulatory Strategy Director

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $220k - $250k / year

⏰ Full Time

🔴 Lead

🧐 Strategy

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Enveda

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $150M Series D - Enveda Biosciences on 2025-09

Healthcare • Consulting • Manufacturing

Enveda is a biotechnology company that leverages a proprietary platform to decode and translate nature’s chemical diversity for accelerated small-molecule drug discovery. By rapidly purifying, identifying, and characterizing molecules from complex natural sources, Enveda aims to put vast, evolutionarily derived chemical space into the hands of drug hunters to discover medicines faster and expand the pipeline of therapeutics.

📋 Description

• Provide regulatory leadership for Enveda's assets through Phase 2 and beyond • Develop innovative global regulatory strategies for Enveda's clinical-development and life-cycle-management portfolio • Lead development of regulatory submissions, including INDs, CTx, briefing documents, IB, NDA, DMF, and IMPD • Identify submission gaps and develop risk-mitigation strategies • Represent Enveda with global health authorities and lead agency interactions • Represent Regulatory Affairs on cross-functional teams as the subject matter expert • Provide regulatory guidance and oversight to global project teams • Ensure regulatory activities comply with health-authority requirements • Coordinate and maintain health-authority reporting schedules • Monitor the regulatory landscape and inform leadership of health-authority initiatives and impacts • Lead, mentor, and develop global regulatory teams • Develop Regulatory Affairs policies, SOPs, and work instructions • Guide cross-functional teams on AI implementation for regulatory dossiers

🎯 Requirements

• Bachelor's degree in a scientific discipline • At least 12 years of Regulatory Affairs experience in pharma or biotech • Strong negotiation skills with health authorities, including FDA, EMA, and Health Canada • Submission experience from IND/CTx through NDA or marketing applications • Experience developing and executing regulatory strategies for oral small-molecule programs • Excellent oral, written, and presentation skills, including experience presenting to leadership teams • Demonstrated organizational awareness and cross-functional representation experience • Excellent planning and organizational skills, with ability to manage multiple projects with tight timelines • 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

🏖️ Benefits

• Equal opportunity employer • Diversity-valuing workplace

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume