Regulatory Affairs Executive

Location
Maidenhead
Salary
30,000 - 40,000
Posted
10 Jan 2019
Closes
19 Feb 2019
Ref
#23904
Contract Type
Permanent
A start up pharmaceutical client is looking for a Regulatory Affairs Executive on a permanent basis. The role is focused on submitting applications via NP and the ideal candidate would be responsible for mentoring junior regulatory team members as well as liaising with relevant regulatory authorities.

The role is based in Maidenhead and salary is paying up to £40,000.

As the Regulatory Affairs Executive you would be responsible for preparing and submitting applications in accordance with deadlines to MHRA via National Procedure.

The candidate would be implementing activities associated with variations, labelling changes, remediation dossiers and license transfers. There will be the need to communicate and liaise with regulatory authorities in gaining the approval of submissions.

In the position, you would look to mentor and provide training to junior team members. Maintenance associate with Marketing Authorisations as well as providing broader regulatory support across the company will form a key part of the role.

The desired candidate would plan and develop briefing documents for meeting with Regulatory Agencies. Providing input and reviewing the submissions documentation to ensure everything is fit for purpose will be an essential part of the position.

Developing protocols according to regional registration strategies will play a part in support of registration and labeling. As the Regulatory Executive you would need to make sure of completion of CTA submission packages according to timeline.

The client is seeking a Regulatory Executive to provide support across registration process, life cycle management and manage submissions in defining submission plans. You would need to advise team on necessary documents and strategy in preparation of MAAs.

For further information, please get in touch with Ross Wilson either at rwilson@keypeople.co.uk or on +44(0)1727 817621.