Overview

Reference Number: JO-2106-470442
Director, CMC Regulatory Affairs
Rate: Negotiable
Job Type: Permanent
Location: United States

Director, CMC Regulatory Affairs

Location: California or remote

CPL Life Science are working with a growing biotech to recruit a Director in Regulatory Affairs CMC (Global). The client is based in California, however, are open to remote working. They are focused on developing precision, cell-targeting investigational therapies within oncology using their technology platform. Within pre-clinical studies they have been shown to cause rapid and selective cell killing and tumour necrosis. Their goal is to create and bring to market drugs and devices to treat cancers based on the platform.

The post holder will assist in implementing global regulatory strategy and CMC standards. The role will focus on ensuring CMC development and standards for IND and commercial stages, device progress and compliance for approvals, BLA readiness and the preparation and review of documents for submission to global agencies.

Key responsibilities:

Ensuring corporate policies and clinical programs are aligned with rules and regulations for global development of pharmaceuticals

Developing and implementing strategies to facilitate timely regulatory application approvals

Overseeing assigned projects and resources

Being involved in the product strategy team to give advice, direction and risk identification on global regulatory requirements and strategy

Working with development teams to write, review and revise documentation for submission to health authorities

Interacting and communicating with health authorities

Requirements:

Excellent knowledge of FDA requirements

Experience within a strategic leadership position

Experience within a pharma or biotech environment

Experience in a CMC regulatory position

This is a fantastic time to join them as they are at an exciting time of development. If you would like to hear more, please send your CV to Rhianna.bellamy@cpl.com

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