Regulatory & Quality Coordinator

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)