Senior Regulatory Officer (Labelling)

Company
AL2S3 LTD
Location
Hatfield, Hertfordshire (GB)
Salary
£50,000 - £55,000
Posted
18 Feb 2021
Closes
20 Mar 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Josh Zarembski is pleased to offer to the market a fantastic opportunity to join a subsidiary of a global pharma company based here in the UK!

This organisation has offices based just 20 minutes north of London and is offering a Senior Regulatory Officer the chance to make a real difference within their labeling team!

You will be part of the team providing high-quality trusted medicines. Have support from the world-leading management team at both a regional and global level with the collective goal of always improving patient & employee health. Finally, be connected to the collective expertise across the world. Connecting people, products & services.

This position can be worked mainly home-based, but in the interest of maintaining a healthy working and social interactions also require a minimum of 2 days working in the office.

Key Responsibilities:
 

  • Awareness of and adherence with Labelling requirements including, but not limited to, relevant internal and external legislation, regulations, standard operating procedures, guidance and templates, etc.
  • Review 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.
  • Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements.
  • Maintaining Company Core Data Sheets and local labelling deviations.
  • Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, 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, supporting Regulatory Leads with, but not limited to, responses to questions and requests for further information, which impact PI texts.
  • Support Brand Leader monitoring process.
  • As required, other Labelling activities required to support the business.


 

 

Desired Qualifications:
 

  • Degree in Life sciences or related area.
  • 3+ years experience of working in a CRO or Pharmaceutical company
  • Knowledge of the regulatory pharmaceutical industry including labeling 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.

To apply please click below

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