Your new company

At SFI Health, we believe we have the responsibility to bring proven natural health solutions to people’s healthcare needs. We are a global natural health company committed to sourcing and producing natural medicines to the highest standards. Backed by evidence of effectiveness, quality and safety, our products are marketed around the world using our international community of leading life sciences companies and distributor networks.

To find out more, please visit https://www.sfihealth.com/

Your new role

We are looking for an experienced and detail-oriented Regulatory Specialist to manage regulatory activities across EMEA, including product registrations, lifecycle management, regulatory writing, formulation review, technical documentation and compliance.

The primary purpose of this role is to ensure compliance with MHRA, Swissmedic, GMP, GDP and applicable European regulatory requirements across the company’s pharmaceutical and nutraceutical portfolio.

Key Responsibilities:

• Own the medicinal product registrations, renewals, variations and lifecycle management across UK, Switzerland, EU, MENA and selected ASIA markets.
• Prepare, review and maintain regulatory dossiers and technical files.
• Undertake regulatory writing for product and regulatory documentation.
• Prepare submissions in eCTD and other required formats & liaise directly with MHRA, Swiss medic and other regulatory authorities.
• Research and interpret relevant legislation, regulatory guidance and industry requirements.
• Conduct regulatory assessments for new products, product changes and existing products & their impact on the company's product portfolio.
• Identify potential regulatory risks and provide practical recommendations to internal stakeholders.
• Review product formulations/recipes, ingredients and specifications to assess regulatory compliance for pharmaceuticals, herbal medicines and nutraceuticals.
• Support maintenance of the company’s Manufacturing and Wholesale Dealers Authorizations with Quality Teams (QA) and Responsible Person (RP).
• Participate in and support audits, inspections and regulatory enquiries where required.
• Maintain an overview of costs compared to budget.
• Support customer service enquiries and Pharmacovigilance activities when requested.