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Employer Hartley People
Job Title Regulatory Affairs Manager
Description

The Role

  • Support the Head of Regulatory and Clinical Affairs regarding activities associated with the registration of products in worldwide markets.

  • Liaise with QA for registered products

  • Ensure all projects are delivered according to timelines

  • Oversee license maintenance support both internally and externally.

  • Manage licensing activities for existing marketing authorization applications worldwide.

  • Strategic planning of regulatory activities in target markets

  • Coach, mentor and develop team.

  • Aid learning and early problem resolution

  • Manage regulatory affairs budgets

The Person

  • Minimum 3rd Level Degree in Chemistry, Pharmacy or Pharmacology but any Science related discipline considered

  • Minimum of 5 years regulatory affairs experience in a supervisory position

  • Strong understanding of cGMP in pharmaceutical manufacturing

  • Strong experience of regulatory approval processes for pharmaceutical products globally

  • Strong communication and people management skills

  • Strong organizational skills

Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent.

For immediate consideration please call Sara on 051-878813 or email your CV in response to this job posting.

Hartley People also recruit for similar roles such as Production Supervisor, Production Manager, Lean Manufacturing, Six Sigma, GMP, FDA, Production, Engineering, Manufacturing, Pharmaceutical, Medical, Devices. ISO 9000, Manufacturing Manager, Operations Manager, Assistant Operations Manager, Production Team Leader, Line Manager, Line Leader

Location Waterford, Kilkenny, Tipperary
Date Added 17 days ago
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