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Global Regulatory & Operations Lead

  1. Dublin
County Dublin
  1. Contract
Competitive
  1. Drug Safety / Pharmacovigilance
21-08-2024
34847
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Global Regulatory & Operations Lead - Operations Lead - Ireland/Dublin

Our client is a global supplier of sterile Injectable pharmaceutical products. They currently market and distribute a portfolio of sterile injectable drugs. Our state-of-the-art research and development organization has a robust pipeline of products in development that we will bring to regulated and semi-regulated markets around the world. These include dosage forms in multidose vials, multiple presentations within the blow-fill-seal offering, and small molecule cytotoxic products.

Responsibilities
  • The need for an understanding of HPRA BoH requirements for hosting a market
  • authorisation.
  • Act as a Responsible Person for a Market Authorisation filing
  • Manage & engage with Global Regulatory colleagues & stakeholders.
  • Communicate & coordinate venders/ service providers - aligning activities & timelines.
  • Build a quality system to manage the MA filing that meets HPRA requirements.
  • Capable of supporting a WDA for release of product into Europe.
  • Regulatory Affairs experience in dossier creation and submission in Europe.
  • Represent the company as the lead person with all the relevant local authorities.
  • Manage Regulatory Affairs activities associated with changes to MAs for all products
  • registered in the territories under his/her responsibility
  • For MAs, directly manage:
  • Creation, maintenance and management of MAs
  • current registered details
  • Build relationships & coordinate with product CMO's & wholesale distributor.
  • Pharma – 380 staff located in Perth.

Your Experience
  • 8-10 year years of professional Regulatory Affairs experience in the Pharmaceutical
  • industry
  • Experience working with the HPRA
  • Experience reviewing regulatory dossiers
  • Excellent communication and stakeholder management skills
  • Experience working with global teams & Regulatory Authorities

If this role is of interest to you, please apply now! 

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