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.

Responsibilities:

• 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.

Requirements:

• 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 matt.thomas@pharma-partners.co.uk