Regulatory Affairs Associate Director

CK Group are recruiting for Regulatory Affairs Associate Director to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis until August 2022.

*Salary:*
Up to GBP57.65 ph PAYE or GBP76.50 ph Umbrella depending upon experience

*Regulatory Affairs Associate Director Role:*

* Strategic and tactical input in development, post–approval and Life cycle management
* Liaison with Regulatory Agencies and Local Operating Companies
* Provide line management, coaching and guidance to Regulatory Professionals as appropriate
* Ensure CTA submission packages are complete and available according to agreed timelines
* Advise team on required documents and submission strategies in preparation of Marketing Authorisation Applications

*Your Background:*

* University degree – medical or paramedical (pharmacy, biology, etc.), or equivalent by experience
* Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
* Experience with EU regulatory procedures (CP, MRP, national)
* Experience with Oncology would be an advantage

*Company:*
Our client is one of the world's leading research–based pharmaceutical companies and is part of a global family of companies.

*Location:*
This Regulatory Affairs Associate Director role will be working remotely with occasional trips to our client's site in High Wycombe, Buckinghamshire.

*Apply:*
Please quote reference 51049.