Associate Director Regulatory Affairs - Herts

CK Clinical
South East England
£65000 to £72000
02 Dec 2017
08 Dec 2017
Contract Type
Full Time
Mary Bolt is recruiting for a Regulatory Affairs Associate Director to join a global pharmaceutical company committed to contributing to better healthcare at their site based in Hertfordshire on a permanent basis.

The main purpose of the role will be to:
- Provide regulatory support to project teams for allocated projects including CTA, variation and PIP submissions.
- Contribute to the planning, execution, and assessment of product life cycle management activities and strategies.
- Contribute to, and implement strategy for interactions and negotiations with health authorities.

Further responsibilities will include:
- Ensuring quality and compliance of regulatory submissions for all assigned projects/products.
- Responsibility for the mentoring of subordinates and other staff as appropriate.
- Becoming the day to day contact point with regulatory authorities for communications relating to assigned projects/products.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Educated to degree level or equivalent experience
- Extensive experience of working with EU regulatory clinical trial procedures
- Life cycle management experience for centralised products
- Excellent communication skills with experience of liasing with health authorities

This is an excellent opportunity to join a dynamic team within a company that has an exciting product pipeline.

Benefits include an excellent salary and benefits package.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL40550 in all correspondence.