Description
My client is urgently seeking a regulatory affairs officer to join their expanding organisation. They are a leading pharmaceutical company based in South Dublin.The role of the regulatory affairs officer will involve:
The preparation, submission and follow-through to approval of new MAAs via national, MR/DC or centralised procedures.
All aspects of post-licensing regulatory work including but not restricted to the preparation and submission of licence renewals, variations and labelling/leaflet applications via national, MR/DC and centralised procedures in compliance with current statutory and non-statutory rules, regulations and guidelines governing medicinal products.
To advise on the regulatory implications of proposals (e.g. changes) with regard to licensed medicinal products, with support.
Liaises with third party partners (e.g. own label suppliers, manufacturers etc) as required in a professional manner to establish and maintain a good working relationship.
Assist in the discussion, initiation and development of departmental processes and procedures.
Participation and compliance with the quality management system.
Maintains as confidential all company files or other materials in good order and secure from inappropriate access at all times.
Develops and maintains familiarity with applicable legislation, guidelines and current industry practices that affect regulatory affairs and the regulation and approval of medicinal products.
To provide support to other departments with regard to the provision of regulatory and technical information.
Requirements for the regulatory affairs officer role:
A 3rd level science degree qualification or equivalent.
Regulatory qualification desirable.
Minimum two experience in regulatory affairs.
3 to 5 years relevant experience in the pharmaceutical industry in particular generics including solid dose, injectable and inhaler products desirable.
Knowledge of EU healthcare legislation and quality requirements.
Excellent personal organisation and planning skills demonstrated through prioritisation of workload.
Demonstrates effective communication style appropriate to audience and situation.
If you are interested in this position please contact me Adele Moran on for more information and for immediate consideration. This is an urgent requirement. An excellent salary and benefits package is on offer and this is a permanent role. Sthree UK is acting as an Employment Agency in relation to this vacancy.