Regulatory Affairs Associate Slough, Berkshire, South East England, England
Job description
Have you got 1-2 years’ experience in Regulatory including submitting post approval variations (Type I and Type II) to MHRA and coordinating post approval filing and other activities?
Have you worked in UK Regulatory Affairs with medicinal products (ideally OTC products)?
Do you have exceptional project management skills and excellent attention to detail?
Are you competent with IT systems and are computer literate?
.....Then please apply today!
Key Responsibilities/ Accountabilities
- 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
- 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.
- Interpret and apply all relevant legislation in the UK 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
Equality
At Reckitt, 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. Come and join a team whose purpose is to protect, heal and nurture in the relentless pursuit of a cleaner and healthier world.
All qualified applicants to Reckitt 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.
