Regulatory Affairs Associate
4 days ago
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Regulatory Affairs Associate
City: Dublin
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
You will work on the front line of Irish regulations, undertaking the activities required to meet the Reckitt Business needs as per defined priorities set by the regulatory management, and ensuring product compliance with all local regulations and Reckitt internal processes.
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
1. 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.
2. Regulatory new products development and compliance for other products categories, as required (e.g. cosmetics, medical devices, food supplements, biocides).
3. 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.
4. Gap analysis of quality dossiers for licensing, including experience in reviewing and quality check of CMC documents for electronic submission to MHRA.
5. Submission of type II safety variations to update SmPC and labelling in line with Company Core Data Sheets.
6. Working with PV on PSUR submissions and SmPC updates.
7. Creation and assessment of internal quality and non-quality changes in line with the change control management system.
8. Artwork review and approvals (PIL, primary and secondary packaging), including preparation of User Test Bridging Reports for the approval of leaflet changes.
The experience we're looking for
1. University Science degree in relevant scientific discipline and regulatory experience within Consumer Health or OTC industry.
2. Thorough understanding of the current Irish regulations, laws, guidelines and industry requirements.
3. Exceptional ability to manage workload and identify priority tasks to meet tight deadlines.
4. Ability to build good relationships and challenge constructively and confidently.
5. Ability to consolidate large volumes of complex information, interpret & construct straightforward plans. Naturally inquisitive and interested in our brands.
6. Confident and capable of operating at all levels and able to resolve conflict situations.
7. Competent with PC tools and information systems.
8. Ability to challenge the status quo and propose improvement.
9. 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.
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.
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