Regulatory Operations Senior Associate

About the role

As a Senior Associate in our Global Regulatory Operations within the RAS Team, in line with the agreed regulatory strategy, you will deliver with optimal execution the relevant medical device dossier and registration documentation, supporting regional and market registration in collaboration with local regulatory teams.

You will ensure operational excellence of your area of responsibility and will align on priorities and resourcing with the Regulatory Operations Manager for Medical Devices.

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.

You will ensure that you work according to internal and external standards, to ensure our dossiers are compliant according to external regulations and internal standards.

You may lead, have oversight of, and manage a team depending on business focus and need.

You will play an important role because…

We’re proud of our organisation and continually strive to be the best that we can be.

The Regulatory Operations Senior Associate plays an essential role to achieve and maintain compliance for new medical device products and existing portfolio.

Your responsibilities

• Responsible for the creation, delivery and maintenance of medical device regulatory dossiers, driving consistency & direction and applying your resource and expertise in line with the agreed regulatory strategy to achieve in market registrations/launches as per planned timings and existing pipeline compliance.
• Managing a complex and diverse set of regulatory requirements and landscape overview across multiple markets in close collaboration with the regional and local teams, accounting for efficiency opportunities and legislation changes locally to optimise data package delivery to markets and communicating these requirements in business friendly language to peers and cross-functional partners / stakeholders in a timely manner.
• Support and deliver training to business partners, materials that optimally prepare the business for the present and future regulatory environment.
• Work in partnership across RAS teams to develop, communicate, and implement the regulatory strategy in collaboration with cross-functional project team and aligns on content of the regulatory submission. Prepare and support submission of registration dossiers whilst ensuring global activities are appropriately assessed for world-wide implications.
• Ensuring you work in partnership with other X-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.
• Be responsible for coordinating 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.
• Responsible for delivering project results following Reckitt’s processes and procedures. Responsible for communicate risks and progress with guidance.
• Supports wider operations teams to achieve targets and understanding of resource requirements. Helps set clear priorities, reviews project progress and is able to develop a gap analysis and implement resolutions.
• Strong understanding of internal business and regulatory processes.
• Responsible for authoring and reviewing departmental SOP/work practices.
• Seek opportunities to drive simplification and opportunities.
• Support audits and au