Description
A leading Bio-pharmaceutical company with a broad and exciting portfolio are currently looking for a Senior CMC Regulatory Affairs Specialist.Candidate criteria;
- Proven significant experience in the biological field
- In-depth knowledge of EU regulatory requirements
- Strong Regulatory writing experience and familiarity of eCTD formats and publishing support functions
Job role;
- Prepare CMC sections of regulatory submissions
- Participate in development of regulatory strategy for new variations
- Participate in analysis activities
- Lead submissions of CMC dossiers
This role is very urgent and the client are looking to conduct interviews ASAP.
If you are interested please apply.