Director, Regulatory CMC

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborates closely with functional leaders to develop optimal pathways for Iovance product candidates, negotiating effective development strategies within internal cross-functional teams and with health authorities, while executing clinical-regulatory development plans on schedule and managing all identified risks.

• Plans, oversees, and prepares Clinical Trial Applications, Market Applications, and their amendments.

• Guarantees that submission documents and correspondence maintain the highest standards of quality in terms of content, organization, clarity, and accuracy.

• Leads cross-functional teams in preparations for meetings with health authorities.

• Ensures that current global regulations, guidelines, and health authority expectations, particularly those pertaining to cell therapies, are integrated into program decision-making.

• Collaborates within the department and with other functional areas to improve processes.

• Must comply with Iovance Biotherapeutics’ core values, policies, procedures, and ethical business practices.

• Performs various additional duties as assigned.

⛳️ Requirements

• Bachelor's degree in life sciences.

• At least 10 years of experience in regulatory affairs.

• Experience in late-stage oncology drug development.

• Proficient in creating and negotiating the clinical-regulatory components of oncology programs.

• Capable of writing, editing, and/or collaborating on the development of high-quality clinical-regulatory documents, such as briefing books, investigator brochures, protocols, clinical study reports, and clinical summaries.

• Able to write clearly and concisely within established timelines.

• Skilled in managing multiple projects and submissions simultaneously, with the flexibility to adapt based on new data, program changes, and external factors.

• Strong attention to detail and accuracy.

• Excellent organizational and planning abilities.

• Capable of influencing and negotiating professionally at various levels within cross-functional teams and with external partners while maintaining positive working relationships.

• Outstanding interpersonal, verbal, and written communication skills.

🏝️ Benefits

• Reasonable accommodations may be provided upon request to enable individuals to fulfill essential functions.