Regulatory Affairs CMC Associate II

The role

The Regulatory Affairs CMC Associate II will coordinate CMC submissions across multiple products. This role involves planning, compiling, and performing quality control for CMC dossier content for clinical and commercial applications.

What you will do

• Support management of the planning, compilation, QC, and submission of CMC dossier content.
• Prepare and adapt submission documents for global clinical and commercial submissions following eCTD specifications.
• Independently plan and prepare routine clinical trial application related amendments and commercial submissions.
• Manage submission trackers for coordination across multiple products.
• Maintain logs of clinical and commercial submissions and correspondence with regulatory agencies.
• Facilitate communication with Vendors/ CROs for planning and tracking source documents.
• Support the implementation of regulatory strategy for assigned projects.
• Work with submission authors and reviewers to ensure high-quality documents.
• Prepare and compile presentations for external and internal audiences.
• Create documents in accordance with eCTD specifications.

Required qualifications

• BS degree
• Minimum 5 years’ experience in regulatory affairs or a related function in drug/biologic development.
• Understanding of US, and Ex-US including international regulations and procedures in drug/biologics development.
• Familiarity with ICH eCTD structure and major market post approval change requirements.
• Advanced skills in using Microsoft Office Suite (Word, PowerPoint, and Excel) and Adobe Acrobat Pro.
• High attention to detail and accuracy.
• Excellent written skills.
• Excellent organizational and planning skills.
• High level of motivation and proactiveness.
• Excellent interpersonal, verbal and written communication skills.
• Ability to work both independently and collaboratively as part of a team.
• Ability to remain in a stationary position standing or sitting for prolonged periods.

Nice to have

• Advanced degree (PharmD, PhD, Master’s)
• Strong scientific or research background, with a focus in pharmacy, chemistry, or biology
• Experience in managing regulatory submissions for investigational or marketed products to global health authorities in eCTD format

About the company

Iovance Biotherapeutics, Inc. is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. The company operates as an end-to-end cell therapy company with U.S.-based manufacturing.