Associate Director, Regulatory Affairs (Fully Remote)

Iovance Biotherapeutics, Inc.; United States; Remote; USD 140,000 - 190,000; Full time

Job summary

Iovance Biotherapeutics, Inc. in the United States is seeking a senior regulatory leader to drive drug development programs and global regulatory strategy.

You will coordinate Clinical Trial Applications, Market Applications, and amendments, and lead cross-functional teams for briefing packages and health authority meetings.

You will ensure evolving biologics and cell therapy regulations shape decision making.

Qualifications

• BS in life sciences with 10+ years regulatory experience.
• Late-stage oncology drug development experience and strong writing skills required.

Responsibilities

• Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments.
• Lead cross-functional teams in preparing briefing packages and health authority meetings.
• Ensure evolving regulations for biologics and cell therapy are incorporated into decisions.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Excellent writing skills

Oncology regulatory experience

Education

BS in life sciences

Advanced degree preferred

Job description

• Lead one or more drug development programs with focus on US and global regulatory strategy.
• Interact with regulatory authorities including Health Canada, MHRA, EMA, Swiss Medic, and TGA.

Responsibilities:

• Plan, manage, and create Clinical Trial Applications, Market Applications, and amendments.
• Lead cross-functional teams in preparing briefing packages and health authority meetings.
• Ensure evolving regulations for biologics and cell therapy are incorporated into decisions.

Qualifications:

• BS in life sciences with 10+ years regulatory experience; advanced degree preferred.
• Late-stage oncology drug development experience and strong writing skills required.

Iovance Biotherapeutics

Iovance Biotherapeutics is a global leader in developing and delivering tumor infiltrating lymphocyte (TIL) cell therapies for solid tumors, with an FDA-approved treatment for advanced melanoma. The company operates as an end-to-end cell therapy organization with U.S.-based manufacturing, serving thousands of cancer patients worldwide.