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, Facebook, Instagram, YouTube and LinkedIn. A Total Rewards package that recognises your value? We offer that Investment in your development? We offer that too Welcome to AbbVie! Our employees work every day to discover and address many of the world's most pressing health challenges. When you have patients depending on your solutions, you look for the best people to be part of the team. We are now recruiting a Senior Regulatory Affairs Officer to join the team at Citywest, Dublin. Reporting to the Head of Regulatory Affairs, this person will be responsible for obtaining and maintaining all necessary licenses (Marketing Authorisations (MA’s), Clinical Trial Authorisations (CTA's) etc.) for a portfolio of products. They will provide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in the development phase. Are you intrigued? Do you want to learn more? A snapshot of your key responsibilities as Senior Regulatory Affairs Officer would be: Submit applications (new MA’s/CTA’s/ 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/Maltese business. Communicate significant regulatory issues/developments to commercial and the potential impact on the AbbVie Business. Liaise with AbbVie European and Global groups, UK, and the Maltese Distributor, on regulatory issues as relevant. Liaise and attend meetings with other company functions to provide regulatory strategy and advice for new and existing products, promotional campaigns etc. Review of product information and promotional material in accordance with legislation, local procedures, and codes of practice. Maintain compliance of regulatory based labelling (Summary of Product Characteristics (SPC), Package Leaflet (PL) and Prescribing Information (PI)). Maintain awareness of current and new legislation/ guidance and ensure that work is compliant with the requirements. Provision of regulatory support during inspections and audits. Provide strategic regulatory input and support to the AbbVie Ireland business. Build relationships with relevant organisations and personnel both internally and externally Anticipate and monitor changes in National and EU regulatory requirements to contribute effectively to product development and regulatory strategies. Qualifications So, what do you need to do this role? Education & Experience: Third level qualifications: Life Science Degree or equivalent. At least four years’ experience of working in a regulatory position is ideal. Mastery of relevant regulations and ability to stay abreast of pertinent regulations. Knowledge and experience of GDP, GCP, and Medical Device regulatory environments would be beneficial. Ability to thrive in a changing environment and to re-prioritise workload to meet business needs. Ability to build strong relationships with peers and cross functionally and with partners outside of the team and company. So, are you ready to join our team? It’s important to remember, AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment. Travel Yes, 5 % of the Time 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.