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.

Responsibilities:

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

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 matt.thomas@pharma-partners.co.uk