Global Regulatory Strategy Director
Enveda · United States · US
Regulatory Affairs
Remote
Pharmacist
Dentist
Demand82
Career growth76
Healthcare fit45
Remote potential30
Salary band
USD 220k – 250k
5-year outlook
Senior director regulatory roles in clinical-stage biotech usually command strong compensation, with equity and pipeline success materially affecting the total package; exact figures are not stated and should be verified.
Clinical license
Not required
Applicant reach
narrow
Seniority
lead
Employment type
full-time
Date found
2026-11-08
Intelligence details
Flexible work details
- Engagement type
- Permanent
- Hours
- Full-time
- Eligible countries
- United States
- Profession fit
- Pharmacist, Dentist
- Rate period
- Annual
Listing via Himalayas.
Eligibility, licensing, and location restrictions can change. Always confirm details on the source posting before applying.
Why this is worth applying to
Worth considering only for clinicians who already have substantial regulatory affairs experience and a track record of global submissions; most clinicians without 12+ years of RA experience should not apply.
Who should apply
Senior regulatory affairs professionals with small-molecule, global submission, and health-authority negotiation experience; clinicians such as PharmDs, PhD-trained doctors, or physician-scientists who have genuinely built a regulatory career in pharma/biotech and are ready for director-level leadership.
CV angle
If you have real regulatory experience, foreground IND/CTx/NDA/MAA submissions, FDA/EMA/Health Canada interactions, oral small-molecule strategy, cross-functional leadership, risk mitigation, and SOP/regulatory operations. Do not reframe purely clinical work as regulatory leadership; only include trial, safety, pharmacovigilance, or medical-affairs exposure where it is genuine and relevant.
Skills to highlight
- Global regulatory strategy
- Health authority negotiation and interactions
- Regulatory submissions from IND/CTx through NDA/MAA
- Small-molecule and oral drug development
- Cross-functional project team leadership
- Regulatory operations and SOP development
- Risk mitigation and compliance planning
- AI-enabled regulatory dossier processes
Role summary
A senior biotech regulatory leadership role responsible for global registrational strategy, health-authority interactions, regulatory submissions, cross-functional guidance, team leadership, and regulatory operations for a clinical-stage small-molecule pipeline.
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