Find More Than 10K+
United Kingdom Jobs

Pharmaceutical Regulatory Specialist

VQ Life Sciences are recruiting for a Permanent Regulatory Specialist to join the Quality team for a leading Pharmaceutical organisation based in Nottingham.

If you have an interest in working in a fast paced, commercial Pharma environment, and have relevant experience in a similar role, we would like to hear from you.

The role is an integral part of the Pharma production unit, responsible for the maintenance of the Regulatory Compliance of the Pharma business unit. The role works collaboratively with the Pharma QA Manager, Head of Quality, business unit teams, other site teams, customers, authorities and inspection bodies.

Responsible for driving continuous quality improvements and developing the business unit to be as self-sufficient as possible.

Your working day will involve:

• Maintaining certification including MIA, controlled drug and pre-curser licenses
• Planning and facilitating regulatory inspections to ensure compliance.
• Liaising with and answering enquiries from regulators e.g., the MHRA and FDA
• Improving internal processes to reduce risk
• Coordinating with clients and team members to review, manage and maintain product compliance files and dossiers.
• Preparing and coordinating licence applications and variations to the MHRA
• Managing the requests for notarised and legalised documentation
• Answering client regulatory enquiries.
• Maintaining the regulatory database
• Providing regulatory advice and guidance
• Participating and contributing in preparation of departmental documentation
• Acting as regulatory contact for deviations, Change controls and relevant meetings.
• Regulatory watch over the Orange guide, ICH and Eudralex
• Coordinating the review of the Pharmacopeia updates.
• Assisting the Head of Quality and Quality Manager in any other required actions to support the smooth running of the Quality Department.

Knowledge, Skills and Experience

• Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Credible and confident communicator (written and verbal) at all levels.
• Strategic thinker with the ability to influence at a senior level.
• Highly customer focused.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a ‘can do’ attitude.

If you have Regulatory experience within the pharmaceutical manufacturing industry and you’re interested in finding out more, please get in touch with David Owen for more information on: 01925596199 or [email protected]

Reference: DO371

Job Features