Senior Regulatory Affairs Officer
- Dublin, Republic of Ireland
- Regulatory Affairs (RA)
This company is a global leader in the pharmaceutical industry. They produce high quality, affordable specialty and branded products. Their products treat a wide range of indications from chronic to acute illnesses. Products fit into the core categories of thrombosis, cytotoxics, nutritionals and anaesthetics. With a heritage spanning over a century, this company has built its legacy to where its products are now available in 150 different countries, produced at 25 different manufacturing facilities across 17 different sites globally. At their virtual Dublin site, they have a friendly and welcoming environment that is patient-focused with a clear progression path for their employees.
As Senior Regulatory Affairs Officer you would be responsible for the management of new applications, variations and the maintenance of international MA's. You will be expected to lead and mentor junior team members and liaise effectively with all stakeholders.
- Lead project teams or working groups as directed by management
- Provide mentoring and support for new starters and less experienced team members
- Develop / deliver training as appropriate
- Peer review of dossier documents for accuracy, completeness and compliance
- Gap analysis and remediation of International CMC documentation
- Manage new applications, variations and maintenance of International MA's
Skills and Qualifications Required
- Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
- Minimum 3 years' experience in a regulatory affairs environment
- Knowledge of EU and other regions current registration and dossier requirements
As Senior Regulatory Affairs Officer you will be, comfortable dealing with multiple projects/tasks at any one time, a good decision maker who will effectively prioritise in order to deal with critical issues and you will deliver results to exceed expectation. You will have excellent communication skills in order to mentor and assist junior team members and to drive projects. You will act with integrity and will strive to take accountability and ownership of your projects.
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To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales