Regulatory Associate

Brentford, Greater London (GBR)
£310 - £313.41 Per Day
12 Months
Start date: ASAP
2 positions available
Ref: GSK0JP00096523

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Required skills

regulatory submissions

Other skills

emc
labelling
spcs
correspondence
marketing
operational support
databases

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/ medicines.ie)

· 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