Director, Regulatory CMC Cell Therapies - Line management & global project leadership for Investigational and Commercial products - Remote

Reference: SMT509D

Expiry Date: 30-11-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
Съединени щати
Remote Working

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Job Description

Remote: East Coast and/or West Coast

This is a great opportunity to join a true pioneer in the area of Cell therapy and Cell therapy development. Our client is a Global Biotech already established as a leader in a number of therapeutic areas including Oncology, Immunology, and Haematology, but their development and registration of CAR-Ts has been ground-breaking.

They are one of only a handful of companies to have their CAR-T products approved and they have a development pipeline that is rated and regarded as one of the most progressive in the industry.

My client has a rare opportunity for an established Regulatory Affairs CMC Director with knowledge of ATMP’s to lead activities for one of their flagship CAR-T products. What’s great about this role is, it that comes with both global strategic leadership and also direct people/team management for a team mostly at Associate Director grade. You will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management and also lead your team to represent regulatory CMC for cell therapy pipeline products - so it’s a good mix of development and lifecycle, a role that covers both investigational and global commercialised projects/products.

Responsibilities:

  • Team leader for a team of 5-6 Regulatory CMC professionals for CAR-T products.
  • Oversee content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Cell Therapy products regarding: Clinical trial applications; New marketing applications; HA responses & background packages (including participating/leading HA meetings); and/or post-approval submissions.
  • Assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
  • Prepare and manage CMC submissions for all global markets while ensuring thoroughness, completeness, and timeliness, including creation and maintenance of strategy documents.

Experience Required:

  • Knowledge of CMC regulatory requirements during development and post-approval.  Experience with global CMC regulations for biological/cell therapy compounds preferred.
  • Knowledge of biopharmaceutical development, including biological drug substance and sterile drug product and analytical methods. Expertise in the cell therapy drug development process and analytical methods, preferred.
  • Demonstrated ability to develop/maintain strong working relationships with the regulatory CMC team and cross functional teams, participate on and/or lead multifunctional teams, handle, and prioritize multiple projects and work independently.
  • Ability to identify, communicate and resolve complex issues. 

On offer is a Lucrative package including a high-end salary for Director grade and a bonus and stock plan rated as one of the best in the industry.

 

To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, on US 908-348-6714 or send us a copy of your resume to cv@advtalent.com. We will support you throughout the interview and on-boarding experience!

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