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Regulatory Associate

Location
Brentford, South East
Job Type
Contract
Posted
6 Aug 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 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 (eg 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 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

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Details

  • Job Reference: 678974534-2
  • Date Posted: 6 August 2022
  • Recruiter: Elevate Direct
  • Location: Brentford, South East
  • Salary: On Application
  • Bonus/Benefits: £313.41 per day Umbrella (inside IR35)
  • Sector: Science & Technology
  • Job Type: Contract
  • Start Date: ASAP
  • Duration: 12 months