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Regulatory Affairs Officer

Employer
Apex International Recruitment Ltd
Location
Hybrid working - 2 days office Surrey, 3 days WFH
Salary
Competitive salary and benefits
Start date
3 Mar 2023
Closing date
28 Mar 2023

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

DETAILS:

  • Full-time permanent position
  • Hybrid working - 3 days WFH, 2 days office Surrey
  • Competitive package

 

THE ROLE:

  • Support the preparation and review of regulatory applications such as variations, change of ownership applications, renewals in the UK, EU and globally
  • Regulatory compliance tracking
  • Regulatory filing and administration
  • Communication of regulatory changes internally and externally
  • Generation, review and implementation of Product Information (Summary of Product Characteristics, leaflets and labelling)
  • Review and processing of certificates of analysis for received product batches
  • Review of stability reports, annual Product Quality Reviews, SOPs, other technical documents and change controls
  • Review and support updates to product Artwork
  • Handling Product Quality Complaints
  • Maintenance of product files (regulatory and technical)

Full job description available on application

 

THE CANDIDATE:

  • Degree in Pharmacy, Chemistry, Pharmaceutical or life science, required
  • 1-2 years+ regulatory experience in UK
  • EU / International Reg Affairs experience essential
  • Demonstrable international regulatory experience essential
  • Only candidates with existing right to work in the UK/EU will be considered

TO APPLY:

Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email alex@apexrecruitment.com

To view our other vacancies, please visit our website on www.apexrecruitment.com

Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.

Company

Apex are a specialist recruitment agency who supply permanent, contract and interim staff to pharma, biotech and CROs across the UK

Our core specialist fields include:

  • Medical Information / Medical Affairs (including Med Info, Scientific Advisors, Medical Advisors, Final Signatory pharmacists and Medics, MSLs, medical directors)
  • Pharmacovigilance / Drug Safety (including QPPVs)
  • Regulatory Affairs

Other specialist fields we recruit for include:

  • QA & QC (including QPs)
  • Healthcare Compliance
  • Clinical Research (including CTMs/CSMs/CRAs/CTAs, CRPs)
  • Health Economics / Market Access
  • Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers)

We have the ability to recruit for the areas above from junior level through to Director level.

Find Us
Website
Telephone
01227 844466
Location
Clover House
John Wilson Business Park
 Whitstable
Kent
CT5 3QZ
GB
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