Job description Posted 03 August 2022

Regulatory Associate

12 Month Contract

Brentford/ hybrid

£313.41 per day Umbrella (inside IR35)

Regulatory Executive

·      Provide Operational Support to deliver identified submissions (including CTAs, MAAs and maintenance activities)

·      Responsible for the regulatory management of assigned products for Ireland and UK (MA and Clinical assets) and may be the primary interface with the regulatory authorities

·      Responsible for assigned non-product specific activities of significance to the department /company

·      Work with key functions and global and local stakeholders to align support for Reg activities

Key Responsibilities

·      Provide support to product related submissions, approvals and artwork activity and associated use of systems where required

·      Responsible for regulatory work delegated by Manager, including the preparation and maintenance of less complex regulatory submissions, the preparation of new/revised SmPC and/or pack text, and the preparation of responses to questions raised by the MHRA and/or HPRA. 

o  Able, with guidance, to liaise with MHRA and/or HPRA in relation to the above

·      Ensure that GSK product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labelling are compliant with MA and with regulatory requirements

·      Responsible for the local management of product registration documents and regulatory agency correspondence in accordance with company procedures.

  • Update of Regulatory Information to external databases (e.g. eMC/

·      Completes Licence Certification activities, including Marketing Authorisation Holder (MAH) review of Periodic Quality Reviews for all registered products in responsible portfolio for which GSK Ireland is MAH

·      Coordination of allocated non product related, cross team projects including general QRM support

·      Work with SMEs to identify updates to existing processes may be required

·      Identify issues requiring resolution and escalate/ resolve appropriately