4 months ago
Job title: Regulatory Affairs Manager - CMC ROW
A top 10 Pharmaceutical company with offices in Berkshire and Cambridgeshire are seeking a Regulatory Affairs Manager. This is a CMC role focused within "Rest of World" international markets.
- Work with Pharmaceutical Development, Analytical, Manufacturing and QA teams to prepare the Quality sections of new marketing authorization applications, post-approval variations, renewals and responses to agency questions
- Act as the regional Regulatory CMC lead for assigned products and territories within a global matrix team
- Co-ordinate regulatory assessments for post-approval CMC changes, develop filing plans for assigned markets and execute filings
- BA/BS, MS or Ph.D or equivalent education.
- Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience.
- Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.
- Biologics experience or drug-device combination product experience would be an advantage, but not essential.
Salary and benefits:
A highly competitive salary, annual bonus, annual stock reward and initial stock reward is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org