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Regulatory Affairs Officer, Labelling

Employer
Achieva Group Ltd
Location
St Albans
Salary
£35000 - £42000 per annum
Start date
1 Nov 2022
Closing date
1 Dec 2022

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Discipline
Regulatory Affairs, Project Management, Regulatory Project Management
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

An excellent opportunity has arised for a Regulatory Officer / Senior Regulatory Officer to join my clients team, with a particular focus within labelling.  This will be an office based role in Hertfordshire - a hybrid model can be considered 

Key responsibilities for this role include:

  • Support initiatives including, Regulatory Labelling Activities associated with organisational growth as a result of company acquisitions.
  • Reviewing of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, Brand Leader (or other Legal Basis Reference Product) and CMC data. As required, this includes locating and confirming the validity of such information.
  • Updating the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements.
  • Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.
  • Working with team to learn Regulatory submission strategy relating to proposed changes to the PI texts.
  • As required, supporting Regulatory Labelling Leads with, but not limited to, responses to questions and requests for further information, which impact PI texts.
  • As required, other Labelling activities required to support the business.

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk

Company

ACHIEVA is an experienced head on new shoulders. 

ACHIEVA comprises five respected specialist recruitment businesses*1, joining forces to become one stronger and more powerful entity, bolstered by research, development and environmental enterprises that share our core values.

We have over three decades of experience in sourcing industry experts across a wide range of specialist sectors including Pharmaceuticals, Primary Care, Occupational Health, Health & Safety, Engineering, Development and Research.

Businesses are people powered. Now more than ever, they want resourceful, motivated and dynamic individuals who have the ability to thrive during times of change as well as the ability to weather any storm. ACHIEVA will find these people and will place them in environments where they will flourish.

ACHIEVA is born out of a recognition that the workplace is evolving and that with change, comes great opportunity. Opportunity for our clients and for our candidates.

ACHIEVA. It’s in the name.

Find Us
Website
Telephone
01727 811634
Location
Second Floor
Blenheim Gate
22-24 Upper Marlborough Rd
 St Albans
Hertfordshire
AL1 3UU
GB
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