Regulatory Operations Associate

We are Reckitt

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. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as stewards of our brands and our company to deliver compliant and competitively positioned products to the people we serve.

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, your key responsibilities will include:

• Delivering medical device dossier and registration documentation, supporting regional and global market registrations in collaboration with local regulatory teams.
• Delivering 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.
• Ensuring operational excellence for your area of responsibility and 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.
• Ensure that you work according to internal and external standards, to ensure our dossiers are compliant according to external regulations and internal standards.

Your responsibilities

• Responsible for the creation, delivery and maintenance of 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 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.
• 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.
  Accountable of delivering project results following Reckitt's processes and procedures. Responsible of communicate risks and progress with guidance.
• 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 audit readiness, both internal and external to Reckitt, with a good level of knowledge in Regulatory guidelines and internal procedures.
• Proactively identify and promote relationships with regulatory partners and cross functional stakeholders to support effective working. Highlight the win-win nature of collaboration.
• Maintain oversight of own resource needs and raise any issues in advance.
• Drive own personal development with the support of line manager, as well as supporting development of individuals within team.
• Ensuring that projects are delivered as per plans and that appropriate and aligned prioritization is implemented.
• Ensuring regulatory information on various systems and databases are kept up to date

The experience we're looking for

• You bring prior experience in Medical Device Regulation or similarly legislative area.
• You have the knowledge and understanding of global product development and maintenance for Reckitt products, rules, regulations and guidelines current and emerging impacting medical device dossiers/regulatory file generation.
• You are educated to degree level in a scientific field or have equivalent experience.
• You develop good peer to peer partnerships and working relationships across RAS and all cross functional teams in the organisation, focusing on achieving common goals for the business.

The skills for success

• You have a keen eye for detail and ability to consistently deliver to time, cost and quality standards in a high-pressure environment with a right first-time approach.
• Demonstrates courage and empathy and work collaborative cross-functionally, through change by adopting a growth and compliance mindset.
• Strategic mindset with demonstrated ability to anticipate future trends accurately, has a broad knowledge and perspective on regulatory implications and risk and has the ability to adapt them to regulatory operations activities.
• Ability to translate complex regulatory information into a compelling stakeholder friendly language.
• You have strong intellectual curiosity with an appetite for exploring new and previously unchartered territories and an openness to change with ability to think out of the box

What we offer

Equality