Remote Associate Director, Regulatory Affairs – Oncology

Iovance; United States; Remoto; USD 185.000 - 210.000; Tempo pieno

Descrizione del lavoro

Iovance Biotherapeutics, Inc. is seeking an Associate Director, Regulatory Affairs to lead US and global regulatory strategy for oncology programs, including interactions with Health Authorities. The role reports to the Senior Vice President and requires deep experience in biologics or cell therapy.

You will manage submissions, drafts, briefing books, and cross-functional teams, ensuring high-quality documents, timelines, and compliance while advancing Iovance's pipeline in solid tumors.

Competenze

• Minimum 5+ years in regulatory affairs with doctorate (MD/PhD/PharmD) or 8+ years with a Master's, or 10+ years with a Bachelor's.
• Late-stage oncology drug development experience.
• Experience in creating and negotiating clinical-regulatory documents with health authorities (Ex-US).
• Able to write/edit clinical-regulatory documents (briefing books, investigator brochures, protocols, clinical study reports).
• Able to manage multiple projects and submissions with tight timelines.
• Excellent interpersonal, verbal, and written communication skills.

Mansioni

• Lead US and global regulatory strategy for one or more oncology development programs.
• Plan, manage and create Clinical Trial Applications, Market Applications, and amendments.
• Ensure submission documents and correspondence are of the highest quality.
• Lead cross-functional teams in preparing for health authority meetings or interactions.
• Incorporate evolving global regulations into program decision making.
• Collaborate on process improvements within the department and with other functions.
• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

Conoscenze

Regulatory strategy

Health authority meetings

Clinical regulatory documents

Project management

Cross-functional collaboration

Verbal and written communication

Formazione

Doctorate (MD/PhD/PharmD)

Master's degree

Bachelor's degree

Descrizione del lavoro

Iovance Biotherapeutics, Inc. is seeking an Associate Director, Regulatory Affairs to lead US and global regulatory strategy for oncology programs, including interactions with Health Authorities. The role reports to the Senior Vice President and requires deep experience in biologics or cell therapy.

You will manage submissions, drafts, briefing books, and cross-functional teams, ensuring high-quality documents, timelines, and compliance while advancing Iovance's pipeline in solid tumors.