Regulatory Operations Associate Medicines - (12-Month Maternity Cover)
Reckitt
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- Regulatory Operations Associate Medicines - (12-Month Maternity Cover)
- City: Kingston upon Hull
- 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.
- 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.
- About the role
- Regulatory Affairs and Safety 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.
- As Regulatory Operations Associate, you will work across some of Reckitt’s largest brands like Gaviscon, Strepsils, Mucinex and Nurofen. You may also be asked to support work within a different classification area from time to time.
- You will be responsible for the content and timely preparation of new dossiers/registration packages/notification and will also be required to update the relevant parts of dossiers/packages/notifications to support internal file maintenance, variation and registration/notification changes in both the new and post launch part of product lifecycle – delivering new products and protecting the base business. You will strive to maintain an excellent level of compliance for our products globally.
- As an Associate in our Regulatory Operations department within the Regulatory and Safety Function, you will support the optimal and timely execution of projects as a regulatory lead under the responsibility of the global team in line with the operating model and all regional and market requirements.
Management of dossiers/registration and notification is a critical and integral part of Regulatory Operations and the wider Regulatory and Safety organization and, you will support and collaborate with a cross functional team to allow the execution of the operations strategy and delivery of relevant regulatory requirements. You will work with operational excellence within the projects that you are assigned to and will align on your priorities and resourcing with the management team.
- Your responsibilities
- Delivery/creation and maintenance of regulatory dossiers/registration and notifications, ensuring accuracy in line with relevant regulations and requirements.
- Showing an understanding of regulatory requirements in the Medicinal classification.
- Working 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. Preparing and submitting relevant regulatory documentation (eg. dossiers, notifications).
- Supporting simplification and efficiency projects to deliver on Reckitt business ambitions.
- Engaging in dynamic resourcing process to ensure that regulatory deliverables are supported within the wider Regulatory Operations team.
You are also expected to;
- Being responsible for supporting input for responses to Regulatory Agency questions.
- Acting as regulatory operations lead on projects with a clear understanding of a broad set of registration/regulatory requirements across multiple markets meeting project objectives and milestones.
- Being responsible for delivering projects following Reckitt’s processes and procedures. Responsible of communicate risks and progress with guidance.
- Inputting into relevant data packages to maintain and deliver best in class regulatory packages according to regulatory requirements.
- Creating and collating market specific documentation, working with relevant regional regulatory and safety partners.
- Providing input into the strategy on dossier/regulatory file.
- Ensuring dossiers/registrations/notifications and regulatory files are maintained.
- Having a good understanding of internal business and regulatory processes.
- Inputting into departmental SOP/work practices as required.
- Supporting audits and audit readiness activities, both internal and external to Reckitt, as requested.
- Developing good relationships with regulatory partners and cross functional stakeholders to support effective working.
- Maintaining oversight of own resource needs and raise any issues in advance.
- Driving own personal development with the support of line manager.
- The experience we're looking for
- Having scientific credentials with a Bachelor of Science (BSc) / Master of Science (MS) degree in a relevant scientific discipline – such as Chemistry, Biological Sciences, Microbiology, Pharmacy.
- Basic knowledge and understanding of: global product development and maintenance for Reckitt products; rules, regulations and guidelines (current and emerging) that impact dossier/registration and