6 months ago
Job title: Senior Regulatory Affairs Manager - EU Neurology - Home-based
This role will focus on a diverse Neurology portfolio in the EU markets. In the role there will be a mix of clinical development work (scientific advice meetings and prep of CTAs) and post approval work (variations and labelling updates).
- Plan and co-ordinate the writing and reviewing for relevant sections of regulatory submissions (IMPDs, CTAs, MAAs, meeting requests, and briefing documents)
- Manage regulatory activities to maintain EUR and INT commercial licenses.
- Support EU and global clinical trials.
- Coordinate the preparation and timely submission of responses to regulatory agencies.
- Demonstrated understanding and strategic application of regulations and guidelines for drug development.
- Must have experience with electronic Common Technical Document regulatory documents (MAA, BLA, responses and CTAs/INDs).
- Demonstrated understanding of EMA and ICH guidelines.
- Bachelors, Masters or advanced degree in a scientific discipline
Salary and benefits:
A highly competitive salary, annual bonus, car allowance, initial stock reward and wider benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org