Quality & Laboratory

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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