about 2 months ago
Job title: Regulatory Affairs Manager - Virology - Middlesex
A Top 15 Pharmaceutical business are seeking a Regulatory Affairs Manager. This role will be an EU-focused position within their Virology portfolio. This opportunity would allow you to strengthen your EU centralised experience in both a pre and post-marketing setting.
- Co-ordinate regulatory submissions for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- 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
- May be required to lead one or more teams in the preparation of European Union Marketing Authorisation Applications (Centralised Procedure) for Virology products in development.
- 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 EU and good breadth of understanding of European regulations relating to clinical trials would be advantageous.
- Experience of clinical trials applications/amendments in other regions would be a bonus.
Salary and benefits:
A highly competitive salary, annual bonus, car allowance, initial & annual stock reward and further benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org