Overview:
Our client is looking for a Regulatory & Quality Coordinator to be a core member of the Regulatory and Quality team, managing and maintaining Marketing Authorisations in line with business goals and legal requirements in the UK.
- Based in Leatherhead
- £40,000 - £50,000
- Hybrid
- Mon - Fri, 9am - 5:30pm (4pm finish on Friday)
Job specification:
Licence Renewals, Variations & New Applications:
- Manage all applications through the licence process; gathering application documentation, submission to the UK regulatory authorities, monitor progress against set timelines, take appropriate action to minimise delays and resolve any issues and answer agency questions
- Work with Regulatory Affairs to ensure production of accurate documentation for timely submission to regulatory agency
- Address all questions from UK regulatory agencies on all applications in collaboration with global, R&D and business colleagues
- Update regulatory documentation following issue of licences
- Action renewal and variation requirements for new product acquisitions. Be responsible for smooth transition into the business portfolio
- Support filing, progressing and completing procedures. Ensure national requirements are communicated to regulatory affairs and adhered to
- Remain aware of current regulatory environment and, where affected, ensure the business complies.
Artwork
- Ensure artwork complies with UK licences and regulations
- Plan and execute artwork change campaigns to align with manufacturing production schedules to maximise impact of new packaging introduction and minimise packaging write off costs
- Ensure artwork changes following licence renewals and variations are made in line with published timelines
- Maintain adequate processes to ensure monitoring of artwork changes
- Manage the packaging process for new product acquisitions and third-party products into our portfolio ensuring continuous supply and timely introduction of new packaging
Maintenance of Regulatory Database
- Update and maintain databases to ensure information is accurate, renewal dates are known and planned, and information is readily communicated to all interested parties
- Maintain IT systems eg SAP, so stock is not blocked for sale and resolve any issues as needed
Quality:
- Support and help manage the QMS and partner the business to make documented procedures available to all that require them
- Help ensure colleagues are appropriately trained on all necessary procedures
- Attend Quality meetings for critical product quality issues, representing the businesses
- Prepare required documentation for product quality complaints that require Quality/ Market Action
Relationships:
- Develop a broad network of contacts - opinion leaders, key influencers, industry consultants, industry bodies - and maintain good working relationships with them
- Work in partnership with internal stakeholder, nurturing productive relationships built on common goals
- Become and be recognised as a regulatory and quality expert, contributing to country and cluster programmes
- Model best practice with colleagues, proactively welcoming ideas, sharing successes and enabling the team to do the same across the business
- Use you network to influence the environment for the benefit the business
Person specification:
- Bachelor’s degree in related discipline desired; pharmaceutical or science
- IT literate. Able to use standard business software, communication tools and quality management systems
- Experience in regulatory affairs / quality would be ideal
- Experience of the workings and practises of industry bodies e.g. VMD, NOAH desirable
- Understanding of regulatory and quality environment and trends
- Analytically minded with strong attention to detail and problem-solving skills
Additional Information:
- Based in Leatherhead
- £40,000 - £50,000
- Hybrid
- Mon - Fri, 9am - 5:30pm (4pm finish on Friday)