I'm currently looking for a Regulatory Manager (CMC) to join a Biotech based in the London region. As the Regulatory Manager (CMC) you will be responsible for the following:
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Manager (CMC) will be varied, however the key duties and responsibilities are as follows:
1.Responsible for defining and implementing innovative Global CMC strategies, supporting an accelerated approach to support the development of products.
2.Support in the write-up of process descriptions, protocols & analytical procedures to ensure that reports are submission ready for inclusion within Module 3.
3.Provide Regulatory support and guidance to external CDMO's, providing support and guidance.
4.You will have opportunities to work across different regulatory areas, such as clinical and non-clinical, and will get involved in defining and implementing this strategy.
To be successful in your application to this exciting opportunity as the Regulatory Manager - CMC we are looking to identify the following on your profile and past history:
1. Relevant degree within a Bio-pharmaceutical discipline.
2. Proven industry experience working within CMC Regulatory Affairs.
3. A working knowledge and practical experience of Biologics.
Key Words: CMC, Regulatory Affairs, Biotech, Biologics, Regulatory Manager
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.