about 1 year ago
Job title: Regulatory Affairs Manager or Associate Director - CMC
A global clinical research organisation with offices in Central London are looking to expand their regulatory team. These roles will provide full-service support for products within Phase I-IV. Experience within CMC is essential.
- Developing and maintaining PIPs, Orphan Designations, Market Authorisation Applications and other regulatory applications.
- Development and review of regulatory submission documents with a specific focus on CMC
- Interaction with regulatory bodies such as EMA and MHRA.
- Providing regulatory advice for various internal teams to ensure compliance with UK and EU regulations.
- Experience within CMC is essential.
- Knowledge and understanding of EMA and MHRA guidelines and regulations.
- Bachelor's degree as a minimum.
- Experience at all stages within the product life cycle.
Salary and benefits:
- Private Medical and Dental insurance
- Company matched pension
- Performance related bonus
- Competitive base salary
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org