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Details

Senior Regulatory Affairs Officer


Reference:BCAOIP-542040 Location: Dublin West
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Our client – a global pharmaceutical company – are seeking a Snr RA Officer for their Commercial base in west Dublin.

Responsibilites:

• 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
• 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
• 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 Irish 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 similiar
• 4 years’ 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

Contact Brian Christensen on 01 6854747 or submit your CV to brian.c@lifescience.ie for immediate consideration
If you would like further Information you can contact the recruiter directly:

Brian Christensen | Tel: +353 (0) 1 685 4747