Manager, Regulatory Affairs
Iovance Biotherapeutics
WorldwideFully remoteFull TimeEntry Level, Mid Level, SeniorHealthcare & Telemedicine
USD 140,000–160,000 a yearPosted 3 months ago3mo agoApply link checked 7 hours ago
Why we think you can apply
- Hiring model
- Open worldwide · the employer states no country restriction
- Work from
- Anywhere, the UAE included
Posted 3 months ago · apply link checked 7 hours ago
About the role
Responsibilities
- Manage the planning, compilation, QC, and submission of INDs, BLAs, and amendments
- Prepare routine IND and CTA amendments
- Work with submission authors and reviewers to ensure high-quality, on-schedule documentation
- Provide regulatory expertise to cross-functional teams
- Assist in developing and managing Gantt charts and submission trackers
- Maintain logs of IND and CTA submissions and agency correspondence
- Prepare submission templates and shells based on company standards
Requirements
- BA/BS degree in a related field
- 8+ years of experience in regulatory affairs for drug/biologic development (or 6+ years with a Master's, or 4+ years with a PhD)
- Experience managing regulatory submissions in eCTD format for global health authorities
- Broad understanding of international regulations, ICH, and regional requirements
- Proficiency in Microsoft Office Suite and Adobe Acrobat Pro
- Strong organizational, planning, and interpersonal communication skills
Preferred Qualifications
- Advanced degree in a relevant field
About the Company
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer by harnessing the human immune system.
What we look for
- BA/BS degree in related field
- 8+ years regulatory affairs experience
- eCTD submission experience
- Knowledge of ICH and international regulations
- Proficiency in Microsoft Office and Adobe Acrobat Pro
ComplianceGMP
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Iovance Biotherapeutics
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