Senior Ra Executive - Berkshire, United Kingdom - Hyper Recruitment Solutions Ltd
Description
We are currently recruiting a Regulatory Affairs CMC Specialist to support a global Pharmaceutical company based in Berkshire As the Regulatory Affairs Specialist you will be responsible for supporting Module 3 regulatory submissions in line with regulatoryrequirements.
Please note the role is initially on a 12 month contract, offering 2 days p/w remote.Your duties as the Regulatory Affairs Specialist (12 months) will be varied however the key duties and responsibilities are as follows:
- Ensure that MAA's are maintained at all times and support the launch of new products.
- The Regulatory Affairs Specialist will respond to agency questions and will work within a global team.
- Relevant degree in a Pharmaceutical discipline.
- Proven industry experience in Regulatory Affairs CMC.
- A working knowledge and practical experience with post approval, regulatory lifecycle maintenance and regulator authority contact.
Key Words:
Regulatory Affairs / RA / Regulatory Affairs Specialist CMC / Module 3 / EU CP / EU Centralised Procedure / Centralised Procedure / Post approvals / EMA / EU Regulatory Affairs / Global
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