- 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
- 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 email@example.com
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 www.collinsmcnicholas.ie
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