Regulatory Affairs Associate

at  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.

THE EXPERIENCE WE’RE LOOKING FOR

• University Science degree in relevant scientific discipline and regulatory experience within Consumer Health or OTC industry
• Thorough understanding of the current Irish regulations, laws, guidelines and industry requirements.
• Exceptional ability to manage workload and identify priority tasks to meet tight deadlines
• Strong influencing / communication expertise
• Ability to build good relationships and challenge constructively and confidently
• Ability to consolidate large volumes of complex information, interpret & construct straightforward plans. Naturally inquisitive and interested in our brands.
• Confident and capable of operating at all levels and able to resolve conflict situations
• Competent with PC tools and information systems
• Ability to challenge the status quo and propose improvement.
• Able to apply appropriate problem-solving techniques to evaluate and resolve operational issues.

THE SKILLS FOR SUCCESS

Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes.

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

ABOUT THE ROLE

As a Regulatory Associate, you’re at the forefront of shaping the synergy between our innovative products and the regulatory framework that guides them. Seeking a meticulous and proactive individual, this role offers you the chance to be the regulatory lead on pivotal projects, honing your communication skills, and nurturing robust partnerships — all while delivering critical tasks that influence our global presence. Your contributions will be impactful and meaningful, as you begin to navigate and influence the regulatory scenery that defines our industry.

YOUR RESPONSIBILITIES

• Regulatory new products development and compliance for UK Marketing Authorisations in Reckitt’s portfolio, including preparation and submission of variation packages and renewals to the Regulatory Agency
• Regulatory new products development and compliance for other products categories, as required (e.g. cosmetics, medical devices, food supplements, biocides)
• 1-2 years CMC experience for UK submission of type I and type II variations (including grouping and work-sharing), such as site transfers, change of manufacturing processes, FSP and analytical methods
• Gap analysis of quality dossiers for licensing, including experience in reviewing and quality check of CMC documents for electronic submission to MHRA
• Submission of type II safety variations to update SmPC and labelling in line with Company Core Data Sheets
• Working with PV on PSUR submissions and SmPC updates
• Creation and assessment of internal quality and non-quality changes in line with the change control management system
• Artwork review and approvals (PIL, primary and secondary packaging), including preparation of User Test Bridging Reports for the approval of leaflet changes.