Manager, Regulatory Affairs

Iovance Biotherapeutics, Inc.

Managing regulatory submissions and ensuring compliance for drug development at Iovance Biotherapeutics. Collaborating with cross-functional teams and maintaining regulatory documentation.

Posted 6/25/2026full-timeRemote • 🇺🇸 United StatesSeniorLead💰 $140,000 - $160,000 per yearWebsite

About the role

Key responsibilities & impact

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.
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.
Perform miscellaneous duties as assigned.

Requirements

What you’ll need

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.

Benefits

Comp & perks

Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Reasonable accommodations may be made upon request to enable individuals to perform essential functions.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsIND applicationsBLA applicationseCTD formatGantt chartssubmission planningQCdocument preparationregulatory expertisedrug/biologic development

Soft Skills

organizational skillsplanning skillsinfluencenegotiationattention to detailinterpersonal skillsverbal communicationwritten communicationadaptabilityrelationship management