Regional Compliance Specialist

4 days ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €110,000
Regulatory Affairs Manager, Europe

 

  • Job Description:
  • We seek a seasoned Regulatory Affairs professional to oversee regional operational activities in the EU markets. As a key member of our Regulatory Affairs department, you will ensure compliance and support regulatory processes for iNova products across the region.

  • Key Responsibilities:
  • Coordinate lifecycle submissions, manage labelling maintenance, and translate as required.
  • Maintain compliance for marketing authorisations in Europe, including third-party held authorisations.
  • Ensure efficient use of internal and external databases and systems.

  • Requirements:
  • A recognised pharmacy, medical or relevant science degree with 4-5 years' industry experience, 3 years' experience in EU countries, and good pharmacological/pharmaceutical/clinical knowledge.

  • Additional Requirements:
  • Occasional business travel within the EU region may be required.

About the Role

As a senior Regulatory Affairs professional, your key responsibilities include managing regulatory regional operational activities within the EU markets to maintain regulatory compliance for iNova products throughout the region.

Key Skills and Qualifications

This role requires a strong understanding of global regulatory frameworks, particularly MRP, DCP, and CP. You should also have solid knowledge of clinical, regulatory, registration, and compliance issues in the EU region and its impact on product development, introduction, manufacture, quality, registration, and marketing.

Benefits

This is an exciting opportunity for an experienced Regulatory Affairs professional to join our team and contribute to the success of our organisation.

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