Senior Regulatory Specialist

6 days ago


Dublin, Dublin City, Ireland Quanta Consultancy Services Ltd Full time

We are seeking an experienced Senior Regulatory Specialist to join our team at Quanta Consultancy Services Ltd, based in Ireland/Dublin. This role offers the opportunity to work on a diverse portfolio of sterile injectable pharmaceutical products, with a focus on global regulatory affairs.

About the Role:

The successful candidate will have 8-10 years of professional Regulatory Affairs experience in the Pharmaceutical industry, with a strong background in working with the HPRA and reviewing regulatory dossiers.

Responsibilities:
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  • Manage global regulatory activities for changes to market authorizations across all European products.">
  • Maintain and update market authorization details to ensure compliance with regulatory requirements.">
  • Foster strong relationships with CMO's, wholesalers, and other key stakeholders to drive business growth.">
  • Act as the Responsible Person for Market Authorization filings and represent the company with local authorities.">
Requirements:
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  • Excellent communication and stakeholder management skills.">
  • Proven ability to work effectively with global teams and Regulatory Authorities.">
  • Capability to support WDA releases into Europe.">
  • Strong expertise in creating and submitting regulatory dossiers in Europe.">


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