Regulatory Affairs Associate

Reckitt Benckiser View all jobs

  • Dublin
  • Permanent
  • Full-time
  • 16 days ago
We are ReckittHome 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 and DevelopmentIn 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.About the roleAs Part of the Regulatory Team - You will work in the Regulatory function, to lead and undertake all regulatory work necessary to meet the needs of the Reckitt business in Ireland as per defined priorities set by regulatory management, and in particular to be responsible for reviewing and submitting variations in compliance with all local regulations and Reckitt internal procedures.Your responsibilities
  • Regulatory compliance for Ireland Marketing Authorisations in Reckitts's portfolio, including preparation and submission of variation packages and renewals to the Regulatory Agency
  • New submissions/eCTD/NeeS
  • Extensive CMC experience for Ireland 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 HPRA
  • 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
  • Work collaboratively with the relevant country teams to establish and implement the regulatory strategies within agreed timescales to bring competitive advantage to Reckitt brands
  • Support UKI Drug Safety Officer and relevant qualified employees to ensure compliance with pharmacovigilance and quality obligations
  • Interpret and apply all relevant legislation in Ireland to keep the Reckitt business up to date on national regulatory trends, risks and opportunities
  • Provide regulatory support and advice to other functions to ensure products are maintained in compliance with the local requirements
The experience we're looking for
  • University Science degree in relevant scientific discipline and regulatory experience within Consumer Health or OTC industry or FMCG
  • Thorough understanding of the current IE and European 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 successCommercial Awareness, Business Partnership, Regulatory, Product Lifecycle Management, Propose improvement, Accountability, Adaptability, Business Strategy, Project & Time Management, Collaboration & Cross-Functional Partnership, Detail Orientation & AccuracyWhat we offerWith 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.EqualityWe 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.

Reckitt Benckiser