Iovance Biotherapeutics
Biotechnology
SeniorRegulatoryAffairsCMCAssociate
“Senior Regulatory Affairs CMC Associate at Iovance Biotherapeutics. Skills: Regulatory affairs, CMC submissions, eCTD format, Global health authorities. Support management of planning, compilation, QC, and submission. Prepare and adapt submission documents for global submissions”
Industry & Context.
Troubleshooting; Problem-solving; Analysis
Remain stationary for prolonged periods, Move about inside an office, Exert up to 10 pounds of force, Visual acuity, Repetitive motion, Substantial movements of wrist, hands, or fingers
What They're Looking For.
Must Have
Minimum 8 years’ experience in regulatory affairs, BS degree, Advanced skills in Microsoft Office Suite, Advanced skills in Adobe Acrobat Pro
Nice to Have
Advanced degree (PharmD, PhD, Master’s), Scientific or research background, 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
What You'll Do.
Support management of planning
Prepare and adapt submission documents for global submissions
Plan and prepare routine clinical trial application amendments
Prepare commercial submissions
Manage submission trackers for coordination
Maintain logs of submissions and correspondence
Facilitate communication with Vendors/CROs
Support implementation of regulatory strategy
Ensure high-quality documents are approved on-schedule
Prepare and compile presentations
Create documents in accordance with eCTD specifications
Adhere to Iovance Biotherapeutics’ core values
Perform miscellaneous duties as assigned
How You'll Work.
Team & Collaboration
Work with diverse internal and external stakeholders; Engage in remote team members; Work independently and collaboratively; Part of a team
Communication Scope
Written correspondence; Verbal communication; Written communication
Process & Methodology
Planning, Organization
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