Job Description
Our client, a pharmaceutical company based in Dublin, now seeks a Regulatory Affairs Officer to ensure that all new licence and variation applications are planned, tracked and obtained in a timely manner in accordance with various EU submission procedures.
The successful candidate will be responsible for assisting in the preparation, creation and submission of new Marketing Authorisation Applications, variations and RFIs to the HPRA, MHRA and other Regulatory Authorities, in compliance with regulations & guidelines.
Responsibilities of Regulatory Affairs Officer:
Compile appropriate documents/files etc. for submission to regulatory authorities/external companies.
Assist with the drafting of departmental procedures and associated documentation.
Maintain and administer the change control log and associated documentation
Participation and compliance with the quality management system.
Maintain databases of key regulatory activities, documentation and confidential company files.
Develops and maintain familiarity with submission of applications to regulatory authorisations in line with applicable legislation, guidelines and current industry practices.
Prepare and compile reports, presentations and meeting information.
Arrange travel flights/hotel accommodation/visas and meetings.
Provide administrative support to all functions of the Regulatory Department and to other departments with regard to the provision of regulatory and technical information.
Project work as and when required.
Requirements for Regulatory Affairs Officer:
Bachelor Degree in Science, Business or related Degree qualification.
2+ years' experience in healthcare industry.
Ideally experience in a similar role, but not essential.
Ability to work well both on own initiative and across all levels, both internally and externally.
Ideally candidates with have strong organization and communication skills, both verbally and in writing.
Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.
Please phone Larry on 01-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Key words; FDA, GMP, R&D, NPI, HPRA, MHRA, Regulatory Affairs, Regulatory Compliance, Reg Affairs, Dublin, Kildare, Wicklow, Leinster, Pharmaceutical.