Manager, Regulatory Affairs CMC

Iovance Biotherapeutics 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 human 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 continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

The Manager, Regulatory Affairs CMC, represents Regulatory Affairs on cross-functional teams, working closely with other team members to support corporate and departmental objectives. An important aspect of this role is the planning and management of submissions. Attention to detail in written correspondence, in the maintenance of regulatory files, and ability to work with diverse internal and external stakeholders are also important factors for success in this role.

Essential Functions and Responsibilities 

• Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments.
• Prepares routine IND and CTA amendments.
• Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule.
• Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics.
• Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program.
• Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development.
• Work within the CMC Regulatory Affairs team to gain consensus on proposed changes.
• Negotiate with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations and guidelines, and industry standards.
• Participate in risk mitigation by proactively identifying risk, developing options and contingency plans.
• Assists in developing and managing Gantt charts (in conjunction with Program Management) and trackers for submissions across the multiple products.
• Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned. 

Required Education, Skills, and Knowledge 

• BA/BS degree in related field required.
• At least 8 years’ experience in regulatory affairs or a related function in drug/biologic development.
• Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format.
• Broad understanding of international regulations and procedures in drug/biologics development; familiarity with ICH and regional regulatory requirements.
• Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
• Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
• High attention to detail and accuracy.
• Excellent interpersonal, verbal and written communication skills.
• 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 (or relevant experience).

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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