Regulatory Affairs Manager

An innovative life sciences organisation is looking for an experienced Regulatory Affairs Consultant to support the development and commercialisation of a growing product portfolio.

This is a strategic role focused on defining regulatory pathways, preparing submissions, building regulatory dossiers, and leading interactions with regulatory authorities. The position will support both near term commercial activities and longer term development programmes, including innovative combination product technologies.

Key Responsibilities:

• Develop and execute global regulatory strategies
• Build and maintain regulatory dossiers and submission packages
• Lead interactions with regulatory authorities
• Support UK, European and future FDA submissions
• Provide regulatory guidance across development and commercial programmes
• Work closely with Clinical, R&D, Quality and Operations teams
• Support products progressing from development through to market

Required Experience:

• Experience with drug device combination products is highly preferred
• Candidates without combination product experience should demonstrate a strong background across both pharmaceutical and medical device regulatory environments
• Experience with MHRA, EU and ideally FDA regulatory pathways
• Proven experience developing regulatory strategies and managing health authority interactions
• Experience supporting innovative or early-stage product development
• Previous experience within start ups, scale ups or fast growth environments would be advantageous
• Comfortable operating in a hands on role with high visibility and influence