Regulatory Program Manager
Our client is a research-focused Pharmaceutical organization, who are one of the world's leading biotech companies, famous for their Oncology portfolio. They are at the forefront of developing ground breaking new medicines and are constantly striving for innovative solutions to healthcare needs.
This company has a very strong regulatory function within the UK office and they are looking for a regulatory professional to join the drug development team and have opportunities at a Senior Manager and Manager level.
Regulatory Program Manager Key Responsibilities:
* Represent the regulatory function on cross-functional global teams in early or late stage projects
* Contribute to the global drug development plan throughout a drugs development and lifecycle
* Lead development of regulatory strategy and risk migration
* Interact and negotiate with Health Authorities for drug development program
* Project issue in EU for CTAs, Scientific Advice and Qualification Advice and/or for MAA/variations
* Communicate with affiliates on project developments and activities
The ideal candidate will have/be:
* 4+ years experience within a Pharmaceutical Regulatory role
* Experience of the regulatory process during clinical drug development and of EU legislation
* Direct interaction with Health Authorities (EMA/CHMP and national)
* Scientific degree preferred
Apply now via this website or contact Rowena Deswert in the Bath office
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.