Regulatory Affairs and Safety Strategy Senior Associate
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
About the role
Want to steer the growth of a major global brand? As a Regulatory Affairs and Safety Strategy Senior Associate you’ll have the freedom to show us what’s possible and help drive innovation that makes an impact. Globally.
Regulatory Affairs and Safety Strategy Senior Associate
Kingston upon Hull, East Yorkshire
Competitive Salary & excellent benefits package including annual performance bonus, 10% pension contribution, private healthcare, hybrid working, shareshave scheme and more!
Hiring Manager: Paulina Lepine (Global Regulatory Senior Manager)
Regulatory and Safety Affairs 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 RB to drive better informed business decisions. We lead the thinking internally about what is possible and put forward ideas that become reality, acting as an stewards of our brands and our company to deliver compliant and competitively positioned products to the people we serve.
You will be responsible for leading the Regulatory and Safety matrix team for key projects within our Pain Category global portfolio, you will have overall accountability for creating & delivering Regulatory and Safety strategies for the innovation and growth projects to product maintenance, risk management and defence activities, all guided by Reckitt purpose, to protect, heal and nurture in the relentless pursuit of a cleaner and healthier world.
- Ensure proper representation of the Regulatory and Safety Strategy Pain Team in multi-functional teams.
- Represent the Regulatory Function with end-to-end oversight and responsibilities of the registration processes (new applications, variations and renewals) at a global level.
- Overall accountable for the Regulatory and Safety end-to-end Strategy for Pain projects from development, innovation and growth projects to maintenance, risk management & defence activities to meet the business objectives.
- Lead the strategy with the corresponding country regulatory affairs contact to define development plans and timings of projects and critical regulatory parameters in data and timings.
- Matrix leadership for the cross functional regulatory focus teams, including all regulatory and safety disciplines and across local teams, to ensure one voice & execution.
- Accountable for the creation and delivery of the product core dossier, to achieve in market registration/launches, giving support to the rest of the team in driving consistency & direction. Ensure appropriate resources and expertise when working with the dossier authors, to ensure consistency and ‘right first time’ approach, in line with the agreed regulatory strategy and in a consistent approach across projects.
- Be responsible for coordinating responses to Regulatory Agency questions.
- Supports work required to refine Regulatory processes and procedures to optimise accuracy and efficiency, thus enabling speed to market.
- Monitor competitive intelligence/regulatory horizon to bring ideas for the category.
- Working with country regulatory affairs, support and where necessary lead Health Authority meetings/negotiations, in support of submission and approval of strategic new product registrations in critical markets
- Work in partnership with the country regulatory affairs teams to identify and be aware of key requirements and that they are considered to deliver a ‘right first time’ approach to new product development.
- Provide strategic oversight for Pain projects across the full product life cycle (maintenance).
- Motivate and lead teams within a results-oriented culture, where personal ownership, being ‘nimble’, strong teamwork, and ‘care for colleagues’ are key.
- 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.
- Maintain oversight of own resource needs and raise any issues in advance.
The experience we're looking for
- You have relevant regulatory and/or safety experience and knowledge in medicinal dossier creation and global registrations across different markets, mainly EU.
- You have relevant regulatory strategic experience on the product development of medicinal products (NPD) and strong understanding of the corresponding rules, regulations and guidelines.
- You are a trusted business partner with proven track record of working closely with cross functional teams to deliver the effective execution of regulatory strategies.
- You will have a sound understanding of regulatory requirements in the medicinal classification. Share knowledge and experience with peers and cross-functional teams. Experience on preparation of Scientific Advice Meetings with Health Authorities.
- Are familiar with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
- Have an ability to consistently deliver to time, cost and quality standards in a high-pressure environment.
- Able to demonstrate courage and empathy to lead cross-functional teams (R&D, Medical, Mkt, Supply, etc) in a matrix organisation.
- Ability to translate complex regulatory information into a compelling stakeholder friendly language.
- You are keen on driving own personal development with the support of line manager, as well as supporting development of individuals within team.
- 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.
The skills for success
- Medical Registration
- Regulatory Affairs
- Regulatory Strategy
What we offer
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.