Vice President, CMC Regulatory Affairs

Overview

The Vice President, CMC Regulatory Affairs has substantial experience leading all aspects of CMC Regulatory Science for Biologic development-stage and advanced stage drug candidates including cell and gene therapy as well as for Biologic commercial drug products. This position requires a strong leader that will provide strategic and operational leadership, and who will ensure the effectiveness of the CMC Regulatory Affairs team. The position is responsible for all CMC-related submission planning and for ensuring that high-quality and accurate submission documents are completed within target timelines. The Vice President can accurately interpret and discuss data within cross-functional teams and with health authorities.

Essential Functions and Responsibilities

• Leads the development and implementation of all CMC regulatory strategy to support global development programs, and market applications for cell therapies.
• Responsible for ensuring the appropriate execution of CMC regulatory strategy.
• Actively seeks out knowledge of overall corporate planning and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge into submission planning.
• Ensures the effectiveness of the CMC Regulatory team in developing submissions and in working across functions.
• Lead the preparation of risk assessments on CMC regulatory topics.
• Builds and manages relationships through active partnering with key internal and external stakeholders.
• Ensure CMC dossiers meet ICH format and content requirements, as well as specific local requirements of individual countries.
• Stay current with regulatory requirements and initiate process improvements as appropriate.
• Analyze and exercise judgment on complex issues, guided by a thorough understanding of CMC.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Experience in biologics drug development, market applications and commercial lifecycle.
• Bachelor’s degree in life sciences required
• 20+ years of pharmaceutical / biopharmaceutical industry experience; 15+ years of relevant biologics experience in Regulatory Affairs CMC.
• Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA.
• Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
• Extensive regulatory management experience and in developing innovative regulatory solutions
• Ability to motivate and lead others
• Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Preferred Education, Skills, and Knowledge

• Advanced degree preferred (PhD, MD, MD/PhD).

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

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 handle work-related stress; ability to handle 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.

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