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Senior Regulatory Affairs Officer - Labelling – Global

Salary

£42,000 - £50,000

Location

Greater London - commutable from Edgware, Uxbridge, St Albans, Slough & Enfield areas

Job Type

Full Time

Reference No: RI3349077634

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Job Description

Working with biologics and innovative pharma products, this Medium Sized Pharmaceutical company are looking to hire a talented Regulatory Labelling professional to cover global regions. The successful candidate will be part of a growing team with a friendly environment. 

 

Location:     Greater London - commutable from Edgware, Uxbridge, St Albans, Slough & Enfield areas

 

Salary:           £42,000 - £50,000 + Bonus and Benefits

 

Job type:        Permanent

 

Responsibilities will include;

  • Providing insight into drug labelling requirements worldwide and procedures for generating, maintaining and rolling out revised labels
  • Previous experience with EMEA and Rest of World regions is desirable
  • Lead the process for company core data sheet (CCDS) development and maintenance, and process for implementation of company core product information for each product and across therapeutic areas
  • Lead discussions with relevant stakeholders regarding roll-out and communications regarding significant labelling changes and mandatory CCSI changes for all products
  • Lead discussions about optimal design/layout of secondary packaging
  • Provide direction for labelling and artwork discussions related to marketed products and products under development
  • Propose templates for key markets
  • Attend project review meetings as relevant (represent the labelling regulatory function)
  • Generation and maintenance of Company Core Data Sheets (CCDS) in close co-operation with product owners
  • Accountable for regular reporting of product IDMP relevant data to the EMA

 For further information please contact Natalie Hopkins on 0207 183 5059 or email natalie@linkfieldgroup.com

Applicant Requirements
  • Previous experience with EMEA and Rest of World regions is desirable
Reference No: RI3349077634
Linkfield Life Sciences are a Regulatory Affairs Recruitment Partner, working with organisations across the Life Sciences sector.

Hiring Manager(s)

Natalie

Head of Regulatory Affairs Recruitment at Linkfield Life Sciences
email: natalie@linkfieldgroup.com

Email Natalie

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