Achieva Group Ltd

Senior Regulatory Officer

Location
Hertfordshire
Salary
£45000 - £55000 per annum
Posted
08 Jul 2021
Closes
07 Aug 2021
Ref
BH-25734-1
Contact
Aine Coles
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
We are assisting a global organisation with their search for a Senior regulatory officer in their labelling department. This is permanent position, that offers remote and flexible work arrangements (in most locations) with a competitive salary and career and development planning for continuous growth and learning.  
 
Key Responsibilities for this role: 
 
Adherence with and awareness of Labelling requirements including, but not limited to, relevant internal and external legislation, regulations, standard operating procedures, guidance, and templates, etc. 
 
Review of PI texts for compliance with relevant mandated safety triggers, Brand Leader (or other Legal Basis Reference Product) and CMC data.  
 
Authoring of the Summary of Product Characteristics, confirming compliance with mandated safety triggers, BrandLeader, CMC and relevant Labelling requirements. 
 
Maintaining local labelling deviations. and Company Core Data Sheets. 
 
Authoring of the Package Leaflet and Labelling, ensuring consistency with the proposed, or approved, Summary of Product Characteristics, relevant safety triggers and Labelling requirements. 
 
Working with Global Product Safety and Risk Management – Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Labelling Committee for endorsement of recommendations. 
 
As required, other Labelling activities required to support the business.  
 
As required, supporting Regulatory Leads with responses to questions and requests for further information, which impact PI texts. 
 
Support Brand Leader monitoring process. 
 
 
The minimum qualifications for this role are: 
  • BSc in Life sciences or related area. 
  • Knowledge of the regulatory pharmaceutical industry including labelling is desirable. 
  • IT literate with proficiency in using Word, Excel, PowerPoint. 
  • Previous experience of Document Management System useful. 
  • Excellent prioritization and time-management skills. 
  • Good verbal and written communication skills. 
  • IT literate with proficiency in using Word, Excel, PowerPoint. 
  • Office acumen, good team player, multitasker, business focused. 
  • Employees, who will initiate customer engagement programs are regarded as the responsible person for the activity and are - as per definition in the applicable SOP - the program owner. 

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