Manager, Regulatory Affairs CMC

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.
• 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.
• Interfaces with Quality Assurance, clinical manufacturing, commercial manufacturing, and other stakeholders to further develop and maintain a robust change‑control program.
• Works with cross‑functional project teams to develop CMC regulatory strategy for product changes at all stages of development.
• Works within the CMC Regulatory Affairs team to gain consensus on proposed changes.
• Negotiates with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations, and industry standards.
• Participates 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 multiple products.
• Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies.
• Adheres to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Performs miscellaneous duties as assigned.

Requirements

• BA/BS degree in a 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.