Senior Regulatory Affairs Officer

  • Reference: 44736
  • Job Type: Permanent
  • Location: Dublin South, Dublin West, Kildare
  • Category: Science, Pharmaceutical & Food

New position – seeking a Senior Regulatory Affairs Officer – DUBLIN – City West – Permanent

Key Deliverables.

  • 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.
  • Deputise in the absence of the Head of Regulatory Affairs.Submit applications (new MA’s/Clinical Trials/Variations/Renewals etc.) for National/EU MA ‘sand 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 the Ireland business.
  • Liaise with other sites 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 
  • 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.


For this role, you should have:

  • A Third level degree qualification in Life Science or similiar
  • 4 years’s plus experience of working in a regulatory position is ideal
  • 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
  • Avialable to travel – circa 5% of the time.


For a confidential discussion and or more information on the role, please contact Mary Mullin  on 09064 78104  / 085 871 8281 or email

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs.

Firstname (required)

Surname (required)

Your Email (required)

Your phone

Upload CV (required)

Security Code captcha


Mary Mullin

Contact Consultant

  • Mary Mullin
  • Midlands Regional Manager
  • 09064 50661
  • Connect with Mary

Job Seekers Guide

Everything you need to know to find a job, including; how to prepare a CV and cover letter, how to prepare for a job interview, how to navigate the modern job market, and much more.
view more