Regulatory Manager

Runcorn
3 weeks ago
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Regulatory Manager – Cheshire – Pharmaceutical – Permanent – Competitive Salary DOE

A growing international company in the pharmaceutical industry with excellent growth already and ambitious plans for the future they are looking to bring on a Regulatory Manager to come and lead their Regulatory team in the Cheshire Area. This role comes with some great benefits including being able to start your weekend earlier with a lunchtime finish on a Friday.

What could your day to day tasks look like?

  • Line management of regulatory team.

  • Assessing new materials and components for their compliance to appropriate regulatory standards.

  • Risk assessing new legislation against current products and materials.

  • Documentation preparation and active participation in PQRs.

  • Manage and facilitate licence and batch specific variation processes.

  • Ensure supplier documentation is maintained and adequately tracked.

  • Actively engage with customers with regards to regulatory issues, concerns or opportunities.

  • Represent the companies interests at the parent companies’ regulatory meetings, industry body groups etc.

  • Act as main point of contact for all consultancies for regulatory purposes.

  • Actively seek to stay on top of new and upcoming legislation whilst also improving overall Regulatory knowledge and support.

  • In addition to these duties and responsibilities listed, the job holder may be required to perform other duties as assigned by the Head of Quality.

    Knowledge and skills / Personal attributes:

    Essential:

  • BSc equivalent or higher in a science-based subject (or 10 years’ experience in a regulated sector in a leadership role).

  • Minimum of 5 years’ experience within a highly regulated sector such as food, pharmaceutical, medica devices in a regulatory role.

    Preferred:

  • Experience in the nutritional supplement industry.

  • Line management experience preferred.

    Benefits:

  • Life Assurance

  • 25 days holiday plus bank holidays (increasing with service)

  • Company Pension (5% employer, 4% minimum employee)

  • Cycle to Work Scheme

  • Discretionary Bonus

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