Regulatory Affairs Department Assistant Job in Citywest, Dublin Ireland
Aspen is a leading supplier of branded and generic pharmaceuticals in approximately 100 countries across the globe and of consumer and nutritional products in selected territories.
Through a process of global expansion, the Group has extended its healthcare reach considerably increasing the number of lives that benefit from Aspen products.
Our extensive basket of products ensures that we are able to treat a broad spectrum of acute and chronic conditions experienced throughout all stages of life.
Aspen is represented in South Africa, Australia, Hong Kong, Kenya, Tanzania, Uganda, Dubai, Germany, Ireland, Mauritius, Brazil, Mexico and Venezuela.
The Group has 18 manufacturing facilities at 13 sites on five continents. Four of the sites are located in South Africa, four in Australia and one of each in Brazil, Germany, Kenya, Mexico and Tanzania.
The following opportunity exists at the Irish-based office of the Aspen Group Regulatory Affairs (RA) department in Citywest, Dublin, Ireland.
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Regulatory Affairs Department Assistant
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Role and Responsibilities
• Assist and provide support to the regulatory team in work assigned related to dossier preparation and compilation (incl. eCTD) for new submissions, variations, and other regulatory filings. Ensure that all required materials are available;
• Ensure all registration submission deadlines are met via timely organisation of the preparation of external experts' reports, organisation of document translations into national languages for respective countries, legalised copies of registration documents, etc.
• Ensure, via cooperation with other functions, that all required registration fees are properly and timely prepaid to relevant Competent Authorities;
• Enter and maintain data in RA electronic systems; ensure electronic information is complete and complies with established company standards; Maintain hard copy RA filing systems in accordance with established company standards.
• Management of all RA-HR and payroll related matters according to the established internal rules;
• General clerical duties including photocopying, faxes, mail, distribution of correspondence, etc.
• Schedule and coordinate meetings, appointments and travel arrangements for RA staff;
• Prepare agendas, record meeting minutes, compile and distribute, etc.
• Maintain office supply inventories
• Coordinate maintenance of office equipment.
Other Responsibilities
- Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of RA and Drug Development for pharmaceuticals for human and veterinary use. Staying up to date with changing regulatory requirements expected.
- Reporting to the Regulatory Affairs Manager, the RA Assistant will work closely with the other Regulatory associates and with colleagues in the other departments.
Skills/Experience
• Minimum 2 years experience in a similar position, preferably in a Regulatory Affairs department;
• Excellent communication and interpersonal skills, plus the ability to multi-task and good organisational skills essential;
• Candidates must be familiar with MS Office, or equivalent computer systems;
• Familiarity with accounting software/packages and other specific pharmaceutical packages (e.g. eCTD) an advantage.
Application References
Submit your CV quoting reference number: IVO-IE-RA1-2012.
Closing date: 20.04.2012
NO Agency contacts or CVs please.