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Director, Regulatory CMC

4 weeks, 1 day ago
Anywhere
Full-time
Lead
Compliance Manager
Technical Writing and Documentation
Apply Now
Iovance Biotherapeutics

Iovance Biotherapeutics

Iovance Biotherapeutics is a biopharmaceutical company pioneering TIL therapy to treat cancer by utilizing the patient's immune system to target cancer cells.

Pharmaceuticals
251-1K
Founded 2007
View All Jobs 8

Description

  • Lead one or more drug development programs with emphasis on global regulatory strategy and regulatory submissions.
  • Work with functional leaders to define the optimal development path for product candidates.
  • Negotiate development paths within internal cross-functional teams and with health authorities.
  • Execute clinical-regulatory development plans on time while managing identified risks.
  • Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments.
  • Ensure submission documents and regulatory correspondence are high quality, accurate, clear, and well organized.
  • Lead cross-functional teams in preparing for health authority meetings.
  • Incorporate evolving global regulations, guidelines, and health authority expectations into program decisions, especially for cell therapies.
  • Drive process improvements within the department and across functional areas.
  • Perform miscellaneous duties as assigned.

Requirements

  • BS degree in life sciences.
  • Minimum 10 years of experience in regulatory affairs.
  • Late-stage experience in oncology drug development.
  • Experience creating and negotiating the clinical-regulatory aspects of oncology programs.
  • Ability to write, edit, and collaborate on high-quality clinical-regulatory documents such as briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries.
  • Ability to write clearly and concisely within agreed timelines.
  • Ability to manage multiple projects and submissions simultaneously and pivot based on new data, program changes, or external influences.
  • High attention to detail and accuracy.
  • Strong organizational and planning skills.
  • Ability to influence and negotiate professionally across cross-functional teams and external partners while maintaining positive relationships.
  • Excellent interpersonal, verbal, and written communication skills.
  • Advanced degree preferred, such as PhD, MS, or PharmD.
  • Experience creating, submitting, and negotiating market applications preferred.

Benefits

  • Annual base salary range of $220,000 to $250,000 USD.
  • Remote office work environment (#LI-remote).
  • Commitment to a diverse and inclusive work environment.
  • Equal-opportunity employment protections.
  • Reasonable accommodations available upon request for applicants and employees.

Interested in this position?

Apply directly on the company website

Apply Now

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