Regulatory Affairs and Safety Associate Self-Care BNL (Brussels, Brussels-Capital Region, BE, 1000) na Reckitt
Reckitt · Brussels, Bélgica · Onsite
- Professional
- Escritório em Brussels
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.
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
Working in partnership with Regional & Global Regulatory, driving operational excellence across the teams incorporating new medicinal product legislation/regulation requirements and industry best practices as required. Cooperation with local business and strategy development + execution in order to capture business ambitions.
You will be a key point of contact to Global Regulatory, Regional Regulatory and local Regulatory teams with respect to OTC medicinal products, relaying knowledge about external factors and internal impact on processes and timings, as well as point of contact for local business leaders and commercial teams
Engage with local trade association working groups to align on regulatory topics and coordinate industry feedback to health authorities, ensuring Reckitt’s interests are represented through collective association initiatives.
Your responsibilities
- Act as Back-up Responsible Person ensuring compliance with Good Distribution Practices (GDP) and maintaining the Quality Management System in the RP’s absence.
- Oversee product quality and compliance - including supplier and customer approval, complaint handling, recalls, and disposition of returned or falsified products.
- Ensure an effective quality management system, self-inspections, and implementation of corrective and preventive actions.
- Lead regulatory strategy and submissions for Self-Care/OTC products in the Benelux region in alignment with the Iberia/France/Benelux.
- Collaborate cross-functionally with Marketing, Safety, and Global/Regional Regulatory teams to secure timely approvals for registrations, artworks, and advertising materials.
- Serve as Drug Safety Officer (DSO) ensuring local implementation of EU and national pharmacovigilance legislation.
- Maintain proactive communication with Health Authorities (RMS role for MRP, DCP, and RUP procedures) and support responses to regulatory queries.
- Participate in regulatory intelligence and post-market surveillance, contributing to EU intelligence reviews, PMS meetings, and Annual Management Reviews.
- Influence external stakeholders, including trade associations and government agencies, on legislative and regulatory developments aligned with company interests.
- Foster a culture of compliance and collaboration, building strong relationships with internal partners and ensuring “right first time” regulatory execution.
The experience we're looking for
- 2–6 years of full time experience in Regulatory Affairs or Drug Safety, preferably within OTC (Self-Care) or pharmaceutical (Rx) products.
- Strong understanding of Benelux (BNL) regulatory requirements and local health authority procedures.
- Proven experience with advertising and promotional material submissions, including copy review and approvals.
- Familiarity with Good Distribution Practices (GDP) and quality management principles.
- Experience in pharmacovigilance and post-market surveillance activities.
- Excellent communication and relationship-building skills, with the ability to collaborate across regional and global teams.
- Fluent in English and at least one local language (French or Dutch); proficiency in both is an advantage.
The skills for success
Commercial Awareness, Business Partnership, Collaboration, Partnership building, Regulatory, Dossier writing, Collaborator, Product Lifecycle Management, Ability to challenge the status quo, Propose improvement, Accountability, Adaptability, Objective Setting, Business 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.
Equality
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.
