Associate Director, Regulatory Affairs

Overview

The Associate Director, Regulatory Affairs, is responsible for leading one or more drug development programs, with specific emphasis on 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. The position reports to the Senior Director, Clinical Regulatory Affairs.

Essential Functions and Responsibilities

• Collaborates closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
• 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 of writing, 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.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• BS degree in life sciences required.
• Minimum 5 years’ experience in regulatory affairs with advanced degree and 7 years with BS.
• Late-stage experience in oncology drug development.
• Experienced in creating and negotiating the clinical-regulatory aspects of oncology drug development programs with health authorities 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 write clearly and concisely, within agreed timelines.
• 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.
• High organizational and planning skills.
• Able to influence and negotiate professionally at various levels within cross-functional teams and with external partners, while maintaining positive working relationships.
• Excellent interpersonal, verbal, and written communication skills.

Preferred Education, Skills, and Knowledge

• Advanced degree preferred (MS, PharmD, PhD).
• Experienced in the creation, submission, and negotiation of market applications preferred.

Physical Demands and Activities Required

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental

Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to manage work-related stress; ability to manage multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.