Job Information
AbbVie #AbbVie Regulatory Affairs Officer in Dublin, Ireland
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .
Regulatory Affairs Officer - 2 year fixed term contract
Role Summary
Obtain and maintain all necessary licenses (Marketing Authorisations (MA’s), Clinical Trial Authorisations (CTA’s) etc. for a designated list of products.
Maintain awareness of current Irish & EU regulatory requirements.
Key Stakeholders
Health products Regulatory Authority
Irish Pharmaceutical Healthcare Association
Responsibilities
Regulatory:
• Submit applications (new MA’s/Clinical Trials/Variations/Renewals etc.) for National/EU MA’s and negotiate 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 regulatory issues/developments to commercial and the potential impact on the AbbVie Ireland business.
• Liaise with AbbVie UK, European and Global groups on regulatory issues as relevant.
• Liaise and attend meetings of other company functions to provide regulatory advice for new products, indications, promotional campaigns etc.
• Review of product information and promotional material prior to release.
• Cover all Regulatory aspects of pharmacovigilance.
Compliance:
• Maintain compliance of regulatory based labelling (Summary of Product Characteristics (SPC), Package Leaflet (PL), Prescribing Information (PI)
• Maintenance and update of all internal required reporting activities and databases (AbbVie 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 AbbVie 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 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.
Qualifications
Qualifications
Third level qualifications: Life Science Degree or equivalent.
3 year working experience with a minimum of 2 years experience required in Regulatory, R&D or related area
Minimum of 1 years experience preferred in pharmaceutical regulatory affairs.
Having experience interfacing with government regulatory agencies and proven skill at developing and implementing successful China regulatory strategies.
Biologics experience a plus. Experience in Gastro, Liver, CV, Urology, CNS, Vaccine, etc. is a plus
Knowledge of regulatory requirements for medicines in EU/Ireland. Knowledge of medical device regulation would be ideal.
Knowledge and experience of GDP and GCP regulatory environments would be beneficial.
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.