This is an exciting opportunity to join the Regulatory Affairs department of a growing pharmaceutical company.
We are looking for a motivated and dynamic individual to join our busy regulatory affairs team as a Regulatory Affairs Officer - EU. The successful candidate will be responsible for planning, organising and managing the product labelling activities for which they have been assigned within the Regulatory Affairs department and ensuring that regulatory submissions are submitted correctly to the concerned authorities to agreed timelines. The role will ensure the individual is motivated to contribute to the effectiveness of the overall team and departmental targets and objectives, and the wider business objectives.
We are looking for someone who has experience in:
- Co-ordination and / or preparation, review, submit and subsequently manage applications to Regulatory Authorities which will include:
- Variations and renewal requests for existing authorisations
- Answers to questions and post registration / approval submissions
- Supporting periodic safety update reports
- Preparation and updating new and previously approved summaries of product characteristics
- Preparation and updating of previously approved product labelling texts and leaflets
- Manage and participate in cross-functional project teams covering
- Compliance with QMS and compliance of products to granted MA
- Procedures and quality policy
- Artwork / labelling
- Collect, review, organise, assemble and check reports and summaries
- Participate in departmental training programmes
- Work with and provide support to third party contractors for assigned projects
- Keep up to date with legislation and regulations and provide regulatory input to internal and external business partners
- Liaise with regulatory authorities and experts relating to regulatory submissions
- Provide information to the International and New Products Group as required.
- Responsible for providing information and data on regulatory and other activities to the Head of Regulatory Affairs
- Where GxP data is generated, ensure that the principles of Data Integrity are adhered to.
- Maintains good knowledge of relevant governance, SOP's and ways of working
Specific Experience Required:
- Pharmacy, chemistry or life sciencies graduate
- Minimum 3 years Regulatory Affairs experience including submission of variations, renewals, new licence application submissions and PSURS
- IT literate with an understanding of e-ctd