Regulatory Operations Specialist – Medicines

Overview

As Regulatory Operations Specialist, you will manage regulatory dossiers and lifecycle activities across medicinal regulations to support timely, compliant submissions. You will work with cross-functional teams to ensure audit-ready documentation and robust regulatory processes. You will navigate a fast-paced FMCG regulatory landscape, maintaining dossier accuracy post-launch and ensuring supply continuity. This role offers impact across global markets, shaping compliant products in Reckitt’s health portfolio.

Pay / Benefits

• Parental benefits
• Employee Assistance Program
• Life insurance for all employees globally
• Global share plans
• Short-term incentives
• Pay-for-performance philosophy

Responsibilities

• Support regulatory requirements across multiple markets to maintain dossier maintenance and post-launch compliance
• Deliver high-quality submissions within agreed timelines and coordinate with partner functions
• Provide GMP documentation support for Reckitt medicinal manufacturing sites globally
• Maintain compliant use of systems and ensure audit readiness across activities

Key requirements

• Experience in regulatory affairs and dossier creation for global registrations
• Knowledge of regional and global regulatory environments and their impact on dossiers
• Experience preparing and submitting medicinal product dossiers and supporting documentation
• Ability to manage multiple projects independently and within a team
• Bachelor of Science in a relevant scientific discipline (e.g., Chemistry, Biology, Microbiology, Pharmacy)
• Strong written and verbal communication to convey regulatory information clearly

• Collaborative
• Results-driven
• Strong communication
• Regulatory dossier preparation
• Global registrations and regulatory submissions
• GMP documentation

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