Role Description The Manager, Regulatory Affairs, 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.

• 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.
• Works 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.
• 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.
• Prepares templates or shells for specific submissions based on company standards.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned.

Qualifications

• BA/BS degree in related field required.
• 8+ years’ experience in regulatory affairs or a related function in drug/biologic development and a Bachelor’s degree, 6+ years with a Master’s degree, or 4+ years with a PhD.
• 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.

Requirements

• Advanced degree preferred (or relevant experience).

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.

Pay Transparency The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills. $140,000 — $160,000 USD Equal Opportunity Statement 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, color, religion, sex, pregnancy, national origin, 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] .