Executive Director, Regulatory Affairs, Global
Celcuity
June 26, 2026
Remote friendly (United States)
United States
Corporate Functions
International / Ex-US Regulatory Affairs Focus
- Supports development and approvals in regions outside of the United States, including experience filing marketing applications ex-US.
- Experience supporting clinical trial applications in regions such as China and Japan is a strong plus.
Position Summary
Reporting to the VP, Regulatory Affairs, the Global Executive Director of Regulatory Affairs leads and participates in global regulatory activities, including regulatory strategy, submissions, and compliance with global requirements. Oversees regulatory activities, coordinates internal/external stakeholders, mentors junior staff, stays current on regulations and industry trends, and mentors/supervises direct reports.
Responsibilities
- Define/develop/lead global regulatory strategies to achieve program objectives.
- Provide regulatory leadership for ex-US marketing applications and CTA development/maintenance for new and ongoing clinical trials.
- Represent regulatory on marketing application submission teams and clinical development/program teams.
- Plan/author/review regulatory documents (e.g., New IND/CTAs, DSUR, Meeting Requests/Briefing Packages, iPSP/PIP, NDA/MAA).
- Lead global regulatory submissions, including responses to health authority requests.
- Oversee submissions for technical accuracy, compliance, and completeness.
- Support compliance initiatives (SOP development, Veeva/documentation initiatives).
- Review clinical documents for regulatory compliance (protocol, ICF, investigator’s brochure, site documentation, required forms).
- Keep current on US and OUS regulations.
- Monitor regulatory compliance with requirements/commitments.
- Develop, mentor, and manage direct reports.
Qualifications
Required
- BS/MS/PhD in relevant scientific discipline; 15+ years biopharmaceutical industry experience and 10+ years regulatory affairs experience, including clinical regulatory affairs for oncology products.
- Independent, self-directed, highly motivated clinical regulatory professional.
- Ability to translate regulatory requirements into practical plans.
- Strong organizational skills and attention to detail; prioritize multiple tasks.
- Ability to build relationships; effective interpersonal/communication skills.
- Track record meeting goals/deadlines in fast-paced environments.
- Experience creating systems/processes for efficient, high-quality regulatory submissions.
- Experience in small/mid-sized biopharma is highly desirable.
Preferred
- Advanced scientific degree with 15+ years regulatory affairs experience.
Benefits
- Annual performance incentive bonus; new hire equity package.
- Medical, dental, vision, 401(k) match, PTO, and paid holidays.
- Supports development and approvals in regions outside of the United States, including experience filing marketing applications ex-US.
- Experience supporting clinical trial applications in regions such as China and Japan is a strong plus.
Position Summary
Reporting to the VP, Regulatory Affairs, the Global Executive Director of Regulatory Affairs leads and participates in global regulatory activities, including regulatory strategy, submissions, and compliance with global requirements. Oversees regulatory activities, coordinates internal/external stakeholders, mentors junior staff, stays current on regulations and industry trends, and mentors/supervises direct reports.
Responsibilities
- Define/develop/lead global regulatory strategies to achieve program objectives.
- Provide regulatory leadership for ex-US marketing applications and CTA development/maintenance for new and ongoing clinical trials.
- Represent regulatory on marketing application submission teams and clinical development/program teams.
- Plan/author/review regulatory documents (e.g., New IND/CTAs, DSUR, Meeting Requests/Briefing Packages, iPSP/PIP, NDA/MAA).
- Lead global regulatory submissions, including responses to health authority requests.
- Oversee submissions for technical accuracy, compliance, and completeness.
- Support compliance initiatives (SOP development, Veeva/documentation initiatives).
- Review clinical documents for regulatory compliance (protocol, ICF, investigator’s brochure, site documentation, required forms).
- Keep current on US and OUS regulations.
- Monitor regulatory compliance with requirements/commitments.
- Develop, mentor, and manage direct reports.
Qualifications
Required
- BS/MS/PhD in relevant scientific discipline; 15+ years biopharmaceutical industry experience and 10+ years regulatory affairs experience, including clinical regulatory affairs for oncology products.
- Independent, self-directed, highly motivated clinical regulatory professional.
- Ability to translate regulatory requirements into practical plans.
- Strong organizational skills and attention to detail; prioritize multiple tasks.
- Ability to build relationships; effective interpersonal/communication skills.
- Track record meeting goals/deadlines in fast-paced environments.
- Experience creating systems/processes for efficient, high-quality regulatory submissions.
- Experience in small/mid-sized biopharma is highly desirable.
Preferred
- Advanced scientific degree with 15+ years regulatory affairs experience.
Benefits
- Annual performance incentive bonus; new hire equity package.
- Medical, dental, vision, 401(k) match, PTO, and paid holidays.