Job title: Regulatory Affairs Manager

A growing business focused on the supply of comparator products, is seeking an experienced Regulatory Affairs professional to join as a Regulatory Affairs Manager. In this role, you will be responsible for conducting all associated regulatory activities on a global scale. Candidates must have an understanding of early access programmes.

Responsibilities:

• Utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for unlicensed supply globally of products on behalf of clients
• Ensure teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities
• Develop and enact appropriate strategies in order to negotiate optimal outcomes for the business and patient on product issues
• Obtain Authority Approvals for Supply of Unlicensed Medicines (Named Patient/Compassionate Use)

Requirements:

• Life sciences or chemistry graduate to honours level or equivalent
• Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
• Extensive UK and EU experience within Regulatory Affairs
• Knowledge of the global unlicensed medicines market and or the Pharmaceutical industry is preferred

Salary and benefits:

A competitive annual salary, annual bonus and pension scheme is on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk