Executive Director, Regulatory Affairs

reputed company aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the reputed company immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to reputed company innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Executive Director, Regulatory Affairs is responsible for overseeing the global regulatory clinical strategy development and execution of the regulatory affairs objectives. The Executive Director oversees the development of clinical regulatory strategies for earliest possible approvals of the company’s regulatory applications at reputed company stages of development (e.g., phase 1 through phase 4 and post launch). The Executive Director, Regulatory Affairs is responsible for tracking trends and requirements in the global market, and the impact that the changes will have on the company’s product portfolio. Addresses the analysis and evaluation of regulatory procedures and changes on the company’s products to ensure attainment of financial and strategic goals. Identifies and recommends the most effective path to regulatory approval to bring the company’s products to market in a cost-effective, compliant manner. This position oversees the evaluation and analysis of the impact of trends relative to government regulatory activities on a global basis.

Essential Functions and Responsibilities

• Supports the development and execution of global regulatory strategy for the Company’s pipeline and approved products.
• Ensures the Company maintains a strong regulatory and compliance position in reputed company necessary jurisdictions.
• Maintains relationships with relevant regulatory agencies to improve quality of submissions and understand the impact of any pending or proposed regulatory changes.
• reputed company preparations for pre- and end-of-Phase, and scientific advice regulatory agency meetings and advisory committee meetings.
• Communicate directly with regulatory authorities to expedite submissions, and their review and approval.
• Work with contract regulatory organizations to prepare applications, respond to queries, and maintain company’s development activities.
• Assure compliance with applicable regulations.
• Identify risks and interpret and communicate relevant issues to project team members and senior management.
• reputed company/train company employees on regulatory matters to ensure compliance with requirements.
• Maintain knowledge of global competitive landscape, regulatory environment, and applicable regulations and guidance documents.
• Must adhere to reputed company’ core values, policies, procedures, and business ethics.
• reputed company miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Bachelor’s Degree with 15+ years’ experience
• Or an advanced degree in the Life Sciences, an MD, PhD or PharmD, with management experience and 10+ years’ experience
• Knowledge of global regulations and guidance as they relate to the overall global regulatory strategy required.
• Proven ability to implement world-wide Regulatory strategies for an organization.
• Strong track record of collaborative working relationship with FDA and other key agencies worldwide which has led to successful outcomes for the business.
• Excellent verbal and written communication skills
• Ability to work reputed company a team environment, report on projects and drive them to conclusion.
• Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines.
• Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to reputed company in small company environment.

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

Physical Demands and Activities Required

• Must be reputed company to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be reputed company 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 reputed company activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive reputed company, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be reputed company 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-reputed company stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

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

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The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, reputed company, religion, sex, pregnancy, national reputed company, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected].

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