Iovance Biotherapeutics
RegulatoryAffairsCMCAssociateII
“Regulatory Affairs CMC Associate II at Iovance Biotherapeutics. Skills: Regulatory affairs, CMC submissions, eCTD, Global health authorities. Support management of planning. Support compilation of CMC dossier content”
Industry & Context.
Troubleshooting; Problem-solving; Analysis
Remain stationary for prolonged periods, Move about inside office, Lift up to 10 pounds occasionally, Repetitive motion, Substantial movements of wrist, hands, or fingers, Maintain remote workspace safely
What They're Looking For.
Must Have
Minimum 5 years’ experience in regulatory affairs, Scientific or research background, Advanced skills in Microsoft Office Suite, High attention to detail and accuracy, Excellent written skills, Excellent organizational and planning skills, Ability to work independently, Ability to work as part of a team, Ability to handle multiple priorities, Ability to meet deadlines
Nice to Have
Advanced degree (PharmD, PhD, Master’s), Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus, Familiarity with ICH eCTD structure, Knowledge of major market post approval change requirements, Ability to assess impact to CMC content
What You'll Do.
Support management of planning
Support compilation of CMC dossier content
Support QC of CMC dossier content
Support submission of CMC dossier content
Prepare submission documents
Adapt submission documents
Plan routine clinical trial application amendments
Prepare routine clinical trial application amendments
Plan commercial submissions
Prepare commercial submissions
Manage submission trackers
Coordinate submissions across products
Maintain logs of submissions
Maintain correspondence logs
Facilitate communication with Vendors/CROs
Track source documents
Ensure high-quality INDs
Ensure high-quality IND amendments
Ensure high-quality CTAs
Ensure high-quality EU-CTR submissions
Support implementation of regulatory strategy
Works with submission authors
Works with submission reviewers
Ensure source document planning is complete
Ensure high-quality documents are approved
Prepare presentations
Compile presentations
Create documents in eCTD specifications
Adhere to core values
Adhere to business ethics
Perform miscellaneous duties
How You'll Work.
Team & Collaboration
Work with diverse stakeholders; Engage with remote team members; Work collaboratively as part of team
Communication Scope
Written correspondence; Verbal communication; Written communication; Presentations
Process & Methodology
Planning, Coordination, Tracking
Applying for this Regulatory Affairs CMC Associate II role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Greenhouse
- Create a Greenhouse profile before applying — it saves time across multiple applications.
- Upload your resume as a PDF; the parser handles it better than Word.
- Answer all knockout questions carefully — wrong answers auto-reject before a human sees you.
- Enable email notifications to track application status in real time.
ANONYMOUS · UNFILTERED
What do employees actually say about Iovance Biotherapeutics?
Real rants from real employees. Read before you apply.