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Executive Director, Regulatory Affairs, Global

1 week, 1 day ago
Anywhere
Full-time
Lead
Compliance Manager
Legal
Apply Now
Celcuity

Celcuity

Celcuity is a clinical stage biotechnology company that unravels complexity and harnesses insights to develop targeted therapies for cancer patients. Their platform provides unparalleled insights into oncogenic pathways, with their lead candidate being...

Biotechnology
11-50
Founded 2012
$214M raised
View All Jobs 10

Description

  • Define, develop, and lead global regulatory strategies to support program objectives and regulatory success.
  • Provide regulatory leadership for ex-US marketing applications and clinical trial application development and maintenance.
  • Represent regulatory affairs on marketing application submission teams and clinical study and development program teams.
  • Plan, author, execute, and review key regulatory documents such as INDs, CTAs, DSURs, briefing packages, iPSP/PIPs, NDA/MAAs, and meeting requests.
  • Lead global regulatory submissions and responses to health authority questions or requests for information.
  • Oversee regulatory submissions to ensure technical accuracy, completeness, and compliance.
  • Support company compliance initiatives, including SOP development, Veeva, and documentation processes.
  • Review clinical documents and required regulatory forms for compliance.
  • Monitor US and outside-US regulations, guidance, commitments, and product/process requirements.
  • Mentor, supervise, and manage work assignments for direct reports.

Requirements

  • BS, MS, or PhD in a relevant scientific discipline.
  • Minimum 15 years in the biopharmaceutical industry.
  • 10+ years of pharmaceutical or biotech regulatory affairs experience, including clinical regulatory affairs for oncology products.
  • Experience filing marketing applications outside the United States.
  • Experience supporting clinical trial applications in regions such as China and Japan is a strong plus.
  • Ability to work independently as a self-directed, highly motivated clinical regulatory professional.
  • Ability to translate regulatory requirements into practical, workable plans.
  • Experience in small and mid-sized biopharmaceutical companies is highly desirable.
  • Strong organizational skills with the ability to manage multiple priorities and maintain excellent attention to detail.
  • Effective interpersonal and communication skills with the ability to collaborate across diverse teams and solve complex technical problems.
  • Advanced scientific degree with 15+ years of regulatory affairs experience is preferred.

Benefits

  • Competitive base salary of $265,000-$300,000 DOE.
  • Annual performance incentive bonus.
  • New hire equity package.
  • Medical, dental, and vision insurance.
  • 401(k) match.
  • PTO and paid holidays.

Interested in this position?

Apply directly on the company website

Apply Now

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