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Regulatory Affairs Manager - Cell Therapy

Cambridgeshire   •  Negotiable  •  Permanent, Full time


Regulatory Affairs Manager (CAR T-Cell Therapy)

Location: Cambridgeshire or Middlesex

Salary: up to 70,000 per annum + package (dependant on experience)

Permanent position

Reference:

CPL Life Sciences are collaborating with a global pharmaceutical business to hire a strategic regulatory professional to support the advancement of immune cells to fight cancer. In this role you work within a small team to drive the regulatory strategy for advance therapies & co-ordinate global MAAs, for products both in development & marketed.

Responsibilities include

-Leading regulatory activities for ATMPs product in development/marketed

-Preparing complex regulatory submissions

-Preparing regulatory documentation to support early phase drug development activities (CTA, PIPs etc.)

-Ensuring working knowledge of global regulations is kept up to date

-Work cross functionally with global teams to ensure optimal execution of regulatory applications

Requirements

-Ideally 5+ years regulatory experience working with Oncology products

-Must have experience working with post marketing activities (Variations, renewals, maintenance), ideally for EU centralized products

-Experience working with CTA within EU would be highly advantageous

-Excellent verbal & written English is a must have, as well as a good work ethic and a collaborative approach to work.

If you would like to apply for this position or discuss our other active positions, please contact Charlie on 01189 522 797 or Charlie.Harris@cpl.com .

  • Agency: Cpl Life Sciences
  • Reference: JO-2206-494639
  • Posted: 19th July 2022
  • Expires: 16th August 2022

Cpl Life Sciences

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