Regulatory Manager
Cambridge/London
Flexible home working
Attractive package
This is an exciting opportunity for a Manager to join the Virology team. You will provide leadership support to the Virology product portfolio in the EU and also support these products as needed for countries including Canada, Australia, Switzerland and UK.
This opportunity would allow you to strengthen your EU centralised experience in both a pre- and post-marketing setting. As part of the Virology team, you will be given opportunities to grow as a regulatory professional and quickly expand your knowledge and experience through the diverse range of regulatory activities you will be involved with.
Some essential requirements include:
- Life Science degree and demonstrated relevant regulatory affairs experience
- Good knowledge of regulatory requirements for the EU centralised procedure
- Experience in co-ordinating post-approval variations, renewals, responses to questions, PSURs etc. for EU centralised products is desirable.
- Experience in clinical trials applications/amendments in the European Union and good breadth of understanding of European regulations relating to clinical trials would be advantageous.
- Experience in working with document management systems
- For licenced products, prepare and/or co-ordinate the submission of non-clinical, clinical and safety regulatory documentation in accordance with regulations, post licensing commitments and legal obligations of the Marketing Authorisation Holder via the European Centralised procedure, e.g. PIP commitments, variations, responses to questions, PSURs etc
- For investigational medicinal products, prepare and co-ordinate regulatory documentation to support early phase development, including Clinical Trial Applications/ amendments and Paediatric Investigation Plans
- Co-ordinate regulatory submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedure
- Acts as regulatory project team representative for specified products.
- Represent International Regulatory Affairs (Int RA) function at cross functional submission/study management team meetings.