Manager, Regulatory Affairs

Remote. Posted 4 months ago

The role

The Manager, Regulatory Affairs represents Regulatory Affairs on cross-functional teams. This person manages the planning, compilation, and submission of INDs, BLAs, and amendments.

What you will do

Manages the planning, compilation, QC, and submission of INDs, BLAs, and amendments.
Prepares routine IND and CTA amendments.
Works with submission authors and reviewers to ensure source document planning is complete and documents are approved on-schedule.
Provides regulatory expertise to cross-functional teams.
Assists in developing and managing Gantt charts and trackers for submissions.
Maintains logs of IND and CTA submissions and correspondence with regulatory agencies.
Prepares templates or shells for specific submissions.
Adheres to core values, policies, procedures, and business ethics.
Perform miscellaneous duties as assigned.

Required qualifications

BA/BS degree in related field
8+ years’ experience in regulatory affairs or a related function in drug/biologic development with 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
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

Nice to have

Advanced degree preferred (or relevant experience)

About the company

Iovance Biotherapeutics, Inc. is a global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies. The company operates as an end-to-end cell therapy company with U.S.-based manufacturing.