Senior Regulatory Affairs Contractor / Consultant / Interim

Senior Regulatory Affairs Contractor / Consultant

Overview:

• Operating at Senior Manager / Director level / above
• Strong technical regulatory experience, particularly in Lifecycle Management (LCM)
• Experience across OTC and prescription medications, including generic products
• Hybrid role, with 3 days per week in office required
• ASAP start

Extensive experience across:

• Lifecycle Management (LCM) activities
• Module 3 (CMC) documentation and submissions
• Post approval activities, including Variations, Renewals, and MA Transfers (MATs)
• Broad exposure to end to end LCM across Europe, ranging from artwork implementation through to regulatory strategy
• Demonstrates a solution oriented approach, leveraging experience to navigate new challenges or support expansion into additional geographies
• Proactive, adaptable, and willing to operate both strategically and operationally
• Strong focus on process development, documentation, and regulatory compliance standards
• Experience supporting organisations expanding beyond the UK/EU, with awareness of broader regulatory considerations
• Management experience

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