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