Regulatory Affairs Officer

  • Dublin
  • Temporary 12 months FTC
  • JO-1901-64183_1548249683

Summary

Responsibilities:

  • Obtain and maintain all necessary licences (Marketing Authorisations (MA's), Clinical Trial Authorisations (CTA's) Etc.) for a designated list of products
  • Maintain an awareness of current Irish & EU regulatory requirements.
  • Submit applications (new MA's/Clinical Trials/Variations/Renewals etc.) for National/EU MA's and negotiates with the Health Products Regulatory Authority (HPRA) to resolve any issues to minimise the delay in approval.
  • Ensure prompt resolution of regulatory issues affecting the Irish business.
  • Communicate significant regulator issues/developments to commercial and the potential impact on Ireland business.
  • Liaise with UK, European and Global groups on regulatory issues as relevant.
  • Liaise and attend meetings with other company functions to provide regulatory advice for new products, indications, promotional campaigns etc.
  • Review of product information and promotional material prior to re lease.
  • Cover all Regulatory aspects of pharmacovigilance.
  • Maintain compliance of regulatory based labelling (Summary of Product Characteristics (SPC), Package Leaflet (PL) and Prescribing Information (PI)).
  • Maintenance and update of all internal required reporting activities and databases (Connect, Launch Excellence, Monthly Report etc.).
  • Maintain awareness of current and new legislation/ guidance and ensure that work is in compliance with the requirements.
  • Develop and maintain regulatory Standard Operating Procedures (SOP's) as required and provision of regulatory support during inspections and audits.
  • Strategic Input & Regulatory Intelligence: provide strategic regulatory input and support to the Ireland business.
  • Build relationships with the HPRA, Irish Pharmaceutical Healthcare Association (IPHA) and other relevant organisations and personnel both internally and externally.
  • Gain regulatory approvals by appropriate negotiation with the HPRA and/or EU and Global groups.
  • Anticipate and monitor changes in National and EU regulatory requirements in order to contribute effectively to product development and regulatory strategies.
  • Monitor the regulatory landscape for generic, parallel import and competitor activity as relevant.


Requirements:

  • A Third level degree qualification in Life Science or similar
  • 1-2 years' experience in a related role
  • Knowledge and experience of GDP and GCP regulatory environments would be beneficial
  • Excellent team working and communication skills
  • Strong negotiation, influencing, presentation skills
  • Strong visionary, strategic, tactical and motivational skills

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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