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Regulatory Affairs Associate

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To lead and undertake all regulatory work necessary to meet the needs of the Reckitt Benckiser business in the UK and to be responsible for ensuring the local company remain in constant compliance with all local regulations and RB international procedures.

Responsibilities / accountabilities; 

  • Regulatory compliance for UK Marketing Authorisations in RB’s portfolio, including preparation and submission of variation packages and renewals to the Regulatory Agency 
  • New submissions/eCTD
  • 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 and registration dossiers for biocides
  • 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 RB brands.
  • Support UK Drug Safety Officer and relevant qualified employees to ensure compliance with pharmacovigilance and quality obligations.
  • Interpret and apply all relevant legislation in the UK to keep the RB 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.

 

Experience required; 

  • University Science degree in relevant scientific discipline and regulatory experience within Consumer Health or OTC industry or FMCG
  • Thorough understanding of the current UK 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.
     
Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Job Segment: Medical, Pharmacovigilance, Healthcare

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