Regulatory Operations Associate

About the Company

We are Reckitt — home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.

Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

About Research & Development

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals — all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

Regulatory and Safety Affairs (RAS) is a critical function within R&D: a key partner in developing the right portfolio strategy for brilliant innovation, activation in our markets and secure the products during all product life cycle. We actively engage externally with stakeholders and regulators to anticipate and credibly influence changes to the regulatory environment, and we bring that regulatory intelligence back to Reckitt to drive better informed business decisions.

About the Role

As Regulatory Operations Associate, you will be responsible for supporting regulatory activities for the compilation, preparation, review and submission of regulatory documents to Notified Bodies and where applicable Health Authorities to support the launch of new innovations, roll outs of new and existing products, maintain local licenses and maintain regulatory compliance though out product life cycle.

As a key member of our Global Regulatory Operations team within the Regulatory and Safety Function, you will form part of the Regulatory Operations team and will connect with the RAS Strategy teams and project teams where input from your department is required. You will be a critical partner of cross-functional colleagues across the Regulatory Strategy and Operations, Consumer Safety, Risk Management/Vigilance, R&D, and Quality across Reckitt to ensure on time and compliant generation of data for medical devices dossier generation and dossier review.

Key Responsibilities

• Deliver medical device dossier and registration documentation, supporting regional and global market registrations in collaboration with local regulatory teams
• Deliver compliance-related activities by providing regulatory guidance to ensure the change can implement according to plan; proactively address unforeseen issues and deliver timely regulatory solutions to maintain compliance and project timelines
• Ensure operational excellence for your area of responsibility and align on priorities and resourcing with the Regulatory Operations Manager for Medical Devices
• Create, deliver and maintain medical device regulatory dossiers in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings and existing pipeline compliance
• Work in partnership across RAS teams to develop, communicate, and implement the regulatory strategy in collaboration with cross-functional project team and align on content of the regulatory submission; prepare and support submission of registration dossiers whilst ensuring global activities are appropriately assessed for world-wide implications
• Partner with cross-functional technical functions like Safety, Quality, Medical, Marketing, Supply, Packaging and R&D as well as other RAS areas and local teams to define requirements for submissions in efficient and timely manner
• Coordinate responses to questions received from regulatory authorities
• Lead projects with a clear understanding of a broad set of registration/regulatory requirements across multiple markets meeting project objectives and milestones; accountable for delivering project results following Reckitt's processes and procedures; communicate risks and progress with guidance
• Author and review departmental SOP/work practices
• Support and deliver training to business partners; prepare materials that optimally prepare the business for the present and future regulatory environment
• Support audits and audit readiness, both internal and external to Reckitt, with a good level of knowledge in regulatory guidelines
• Seek opportunities to drive simplification and improvements
• Ensure that you work according to internal and external standards, to ensure our dossiers are compliant according to external regulations and internal standards