Regulatory Affairs CMC Associate II - Remote-ready

Iovance Biotherapeutics, Inc.; United States; Remote; USD 120.000 - 140.000; Vollzeit

Zusammenfassung

Iovance Biotherapeutics, Inc. is seeking a Regulatory Affairs CMC Associate II to coordinate submissions across products, manage planning, qc, and eCTD content for clinical and commercial applications worldwide.

The role emphasizes accuracy, regulatory expertise, and collaboration with internal teams and external partners. The position requires a BS degree (advanced degree preferred) and at least 5 years in regulatory affairs with strong knowledge of US and international guidelines.

Qualifikationen

• Minimum 5 years’ experience in regulatory affairs or a related function in drug/biologic development.
• Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format a plus.
• Understanding of US and international regulatory requirements (ICH) and eCTD structure.

Aufgaben

• Support management of planning, compilation, QC, and submission of CMC dossier content.
• Prepare and adapt submission documents for global clinical and commercial submissions.
• Independently plan and prepare routine clinical trial application‑related amendments and commercial submissions.
• Manage submission trackers for coordination across multiple products.
• Maintain logs of submissions and correspondence with FDA or other authorities.
• Collaborate with Vendors/ CROs for source documents to ensure timely IND/DSUR/CTA submissions.

Kenntnisse

Regulatory affairs

CMC submissions

eCTD knowledge

Attention to detail

Written communication

Cross-functional collaboration

Ausbildung

BS degree

Advanced degree preferred

Tools

Microsoft Office

Adobe Acrobat Pro

Jobbeschreibung

Iovance Biotherapeutics, Inc. is seeking a Regulatory Affairs CMC Associate II to coordinate submissions across products, manage planning, qc, and eCTD content for clinical and commercial applications worldwide.

The role emphasizes accuracy, regulatory expertise, and collaboration with internal teams and external partners. The position requires a BS degree (advanced degree preferred) and at least 5 years in regulatory affairs with strong knowledge of US and international guidelines.