Global Regulatory Affairs & Safety Strategy Manager
We are Reckitt
Research & Development
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
Your responsibilities
The Global Regulatory Affairs & Safety Strategy Intimate Wellness has a large global remit, that will be responsible for leading the Regulatory and Safety Strategy end to end for our Intimate Wellness global business.
•Be the voice of Regulatory Affairs and Safety Strategy for your pod(s) and represent the Regulatory & Safety function within all applicable forums as required.
•Represent the Regulatory Function with end-to-end oversight and responsibilities of the registration / notification processes around the world
•Have overall accountability for the Regulatory and Safety E2E (end to end) Strategy for your products/projects, from development, innovation and growth projects to maintenance, risk management and defence activities to meet the business objectives
•Establish overarching global regulatory strategies, fully aligned with corporate strategy and local requirements and considerations, through your pods.
•Manage a complex and diverse set of registration/regulatory requirements across multiple markets to enable strategic global pipeline delivery. Lead the strategy with the corresponding country regulatory affairs to define development plans and timings of projects and critical regulatory parameters in data and timings.
•You will work internally to support interpretation of new requirements or regulation changes, ensuring team understanding and externally to support development of requirements and advocacy in line with Reckitt’s vision and purpose.
•Lead a cross functional RAS team through the matrix to ensure one voice and execution.
•Be accountable for delivery of the product core dossier/technical files, to achieve in market registration/launches, giving support to the rest of the team in driving consistency and direction. Ensure appropriate resources and capabilities are deployed through your RAS pod to ensure consistent and “right first time” approach, across projects.
•Support the work required to refine Regulatory processes and procedures to optimise accuracy and efficiency, thus enabling speed to market.
•Work with country regulatory, support and where necessary lead with them, Health Authority meetings/negotiations in support of submission and approval of strategic new product registration pathways in critical markets
•Work in partnership with the local regulatory teams to identify and be aware of key requirements and to ensure that they are considered to deliver a ‘right first time’ approach to new product development. Identify efficient pathways to markets by challenging the status quo.
•Deliver within a results-oriented culture, where personal ownership, being ‘nimble’, strong teamwork, and ‘care for colleagues’ are key.
•Devise, and deliver to business partners, training materials that optimally prepare the business for the present and future regulatory environment.
The experience we're looking for
•You have 5+ years’ relevant regulatory and/or safety strategic experience of Health/Hygiene products and across multiple product classifications (medical device, cosmetics…) and regions. Relevant Regulatory Experience and knowledge in new product development (NPD) and dossier/technical file creation and global registrations
•You are a trusted business partner with proven track record of working closely with commercial leaders to deliver robust strategic plans and strong interface with senior functional members.
•You bring significant prior experience leading related product development leading global end-to-end programs, from innovation to maintenance and defend/advocacy strategies, with a strong track record of successful projects delivered across multiple categories and regions. You will have a good understanding of global product development practice for Health products, rules, regulations and guidelines.
•You are experienced in preparing and submitting dossiers, variations and renewals.
•You have familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier/product deliveries.
•You can communicate regulatory strategies simply and efficiently to a non-regulatory audience as well as changes to the business as required.
•You have high scientific credentials with a Bachelor of Science (BSc) / Master of Science (MS) degree in a relevant scientific discipline – such as Chemistry, Biological Sciences, Microbiology, alongside significant applied industry experience.
•You can demonstrate courage and empathy to lead cross-functional teams in a matrix organisation
•You have excellent communication skills in English and Chinese
The skills for success
What we offer
Equality