Executive Director, Regulatory Affairs – Global

Celcuity

Executive Director leading global regulatory affairs for biopharmaceutical company, focusing on international regulatory strategy and compliance for oncology products.

Posted 5/15/2026full-timeRemote • 🇺🇸 United StatesLead💰 $265,000 - $300,000 per yearWebsite

About the role

Key responsibilities & impact

lead and participate in global regulatory activities
develop innovative global regulatory strategies
provide strategic regulatory guidance for global development
coordinate with internal and external stakeholders
mentor junior staff
oversee regulatory activities and submissions
ensure compliance with global regulatory requirements

Requirements

What you’ll need

BS/ MS/ PhD in a relevant scientific discipline
minimum of 15 years in the biopharmaceutical industry
10+ years of experience in pharmaceutical or biotech regulatory affairs
experience in clinical regulatory affairs for oncology products
ability to translate regulatory requirements into practical workable plans
diverse experience with regulatory activities
strong organizational skills
effective interpersonal and communication skills
demonstrated ability to achieve high performance goals in a fast-paced environment

Benefits

Comp & perks

annual performance incentive bonus
new hire equity package
medical insurance
dental insurance
vision insurance
401(k) match
PTO
paid holidays

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesregulatory guidanceregulatory activitiesregulatory submissionsclinical regulatory affairsoncology productscompliancebiopharmaceutical industrypharmaceutical regulatory affairsbiotech regulatory affairs

Soft Skills

mentoringorganizational skillsinterpersonal skillscommunication skillsstrategic thinkingcollaborationleadershipproblem-solvingadaptabilitygoal achievement

Certifications

BS in relevant scientific disciplineMS in relevant scientific disciplinePhD in relevant scientific discipline