Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

Location: Cambridge, Homeworking flexibility on offer

Salary: Highly competitive salary & package including long-term incentives

Permanent position

Reference number: JO-2107-471746

CPL Life Sciences are collaborating with a global pharmaceutical business to hire an experienced strategic regulatory professional to support the advance of complex medicines to patients in need. In this role you will take responsibility of a small team to drive regulatory strategy & co-ordinate EU centralized procedure applications.

Responsibilities include.

-         Drive regulatory strategy on assigned products in EU and support other global countries

-         Co-ordinate submissions for assigned projects in line with ICH requirements

-         Manage products in both pre-and post-marketing phase

-         Prepare and co-ordinate documentation to support early phase development including CTAs and PIPs

-         Prepare and coordinate submissions of clinical, non-clinical, and safety regulatory documentation

-         Direct line management of a small team

Requirements

-         Must have worked extensively with EU centralized procedure applications in both pre and post-marketing phase

-         Must have a relevant life science degree and a good scientific background

-         Experience working with CTAs in Europe would be highly advantageous

-         Line management experience isn’t essential but highly advantageous

If you would like to apply for this position or discuss our other active positions please contact Charlie on 01189 522 797 or [email protected] .