- 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.
- 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.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists