10 months ago
Job title: (Senior) Regulatory Affairs Manager - EU Development Focus
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 development phase products across a range of therapy areas.
- Maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations and Market Authorisation Applications (MAAs)
- Develop and review of regulatory submission documents for Interaction with EMA, MHRA, and other regulatory agencies
- Developing scientific and regulatory documents for EU agency meetings.
- Providing regulatory advice and guidance to Sponsors and other cross functional departments to ensure compliance with UK and European regulations and requirements
- Experience with EMA, MHRA and other EU regulatory agencies is preferred
- Experience within Paediatric Investigation Plans (PIPs), Orphan Designations, and Market Authorisation Applications (MAAs) is essential
- 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