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Senior Regulatory Affairs/Pharmacovigilance

My client are healthcare company based in Northeast Dublin. They have a portfolio of healthcare products including medicines, medical devices, foods for special medical purpose and foods supplement.As Senior Regulatory affairs/Pharmacovigilance officer you will be working on a great team.

This is a permanent role and offers a 3-4 day work week.

What you will be doing as a Senior Regulatory Affairs/Pharmacovigilance Officer?

  • Create and execute Regulatory Strategies related to existing and new MAA's.
  • Preparing and submitted of new MAA's across multiple territories (primarily EU) using DCP
  • Preparing and managing international regulatory submissions in accordance with commercialisation plan.
  • Renewing and updating product certificates/authorisations in company's territories
  • Providing regulatory support for out-licensing activities in EU and non-EU territories
  • Reviewing data to ensure suitability of dossiers/technical files for submission
  • Managing post-licensing activities (variations, renewals, PSURs, etc.) within EU and Non-EU territories.
  • Track registration variations and Health Authority Commitments, related to company medicinal products.
  • Obtaining information and keeping up to date on regulatory compliance and guidelines prepared by National Regulatory Agencies and Notified Bodies
  • Processing queries from licensees and distributors on regulatory matters and supporting them where possible
  • Performing regulatory compliance activities such as SOP revising, gap analysis, reviewing company specifications, change controls and involvement and eCTD project.
  • Assist with Regulatory related audits by competent authorities or third parties.
  • Perform registration compliance reviews.
  • Assist with Regulatory Projects such system improvement or adapting to forthcoming regulations.
  • Assist the QPPV/dQPPV with Pharmacovigilance compliance activities.
  • Coordinate Safety Data Exchange Agreements with Kora Healthcare partners and distributors ensure all parties are following their PV obligations and responsibilities
  • Carry out weekly/bi-weekly PV related checks related to established PV procedures to ensure the smooth and successful running of the Pharmacovigilance system.

What I need to be Senior Regulatory Affairs/Pharmacovigilance Officer?

  • The ideal candidate will have at least 5 years regulatory experience in the pharmaceutical industry and have a life science or pharmacy degree.
  • Knowledge and understanding of the EU regulatory frameworks for medicinal products.
  • International Experience of registration/variation of Medicinal Products and Medical Devices
  • Experience within Regulatory Strategy and its execution
  • Good understanding of the content and format of MA registration files (CTD) with the ability to prepare high quality submissions
  • Practical experience of registration and variation procedures in the EU (national/MRP/DCP) using electronic applications (both NeeS and eCTD).
  • Previous experience with the preparation and submission of new MAAs (Well-established Use) in the EU using DCP route.

Don't miss out on the opportunity to work for a great company with some great benefits.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales