Overview
The Associate Director, Regulatory Affairs, is responsible for leading one or more drug development programs, with specific emphasis on US and global (Ex-US) regulatory strategy, regulatory submissions, and interaction with global regulatory authorities including Health Canada, MHRA, EMA, Swiss Medic and TGA. The ideal candidate must have a good understanding and experience in clinical development strategies and health authority expectations for biologic products with novel cell and gene therapy for oncology indications preferred.
Essential Functions and Responsibilities
- Collaborates closely with functional leaders to create the optimal development path for Iovance product candidates, negotiate development paths within cross-functional teams, and execute clinical-regulatory development plans.
- Plans, manages, and creates Clinical Trial Applications, Market Applications, and amendments.
- Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
- Leads cross-functional teams in developing strategic briefing packages and in preparing for health authority meetings or interactions.
- Ensures that evolving global regulations, guidelines, and health authority expectations, especially those related to biologics or ATMPs such as cell therapy products, are incorporated into program decision making.
- Works within the department and with other functional areas on process improvements.
Required Education, Skills, and Knowledge
- BS degree in life sciences required.
- Minimum 10 years’ experience in regulatory affairs with a Bachelor’s degree, 8 years with a Master’s degree, or 5+ years with a PhD.
- Late‑stage experience in oncology drug development.
- Experienced in creating and negotiating the clinical-regulatory aspects of oncology drug development programs with health authorities, including Ex-US.
- Able to write, edit, and/or collaborate on the development of high-quality clinical-regulatory documents, e.g., briefing books, investigator brochures, protocols, clinical study reports, clinical summaries.
- Able to simultaneously manage multiple projects and submissions, with flexibility to pivot based on new data, program changes, and/or external influences.
- High attention to detail and accuracy with strong organizational and planning skills.