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