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Regulatory Affairs CMC Associate II at Iovance Biotherapeutics - ApplyBlast

Regulatory Affairs CMC Associate II

Iovance Biotherapeutics

5 months ago

2.5 on Glassdoor

Hybrid

Full Time

Senior

0 applicants

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About this role

Iovance Biotherapeutics is seeking a Regulatory Affairs CMC Associate II to coordinate clinical and commercial submission plans for multiple products. This role involves preparing eCTD-compliant documentation, managing submission trackers, and facilitating communication with vendors and regulatory agencies to ensure timely delivery of high-quality dossiers.

Responsibilities

Coordinate CMC submissions across multiple clinical and commercial products
Prepare and adapt eCTD-compliant submission documents for global markets
Manage submission trackers for diverse internal and external stakeholders
Facilitate communication with vendors and CROs for source document planning
Support implementation of regulatory strategy for projects from IND to approval

Skills

Qualifications

BS Degree in PharmacyPhD in ChemistryMaster's in BiologyPharmD

About Iovance Biotherapeutics

iovance.com

Headquarters

San Carlos, California, United States

Company Size

501-1000 employees

Founded

2007

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Iovance Biotherapeutics is a clinical-stage biopharmaceutical company developing tumor-infiltrating lymphocyte (TIL) therapies for solid tumors. Its lead product Amtagvi (lifileucel) is being investigated in multiple clinical trials, with manufacturing conducted at the Iovance Cell Therapy Center in Philadelphia, PA, and collaborations with academic and industry partners to advance next-generation TIL platforms.