Regulatory Affairs Manager (CMC)

Location: Liverpool
Salary: £50,000 - £60,000 + Bonus, Pension, Relocation Assistance

Regulatory Affairs Manager
Liverpool
£50,000 – £60,000 + Benefits

Opportunity to join a leading pharmaceutical business based in the Liverpool region. This organisation work across a range of industries including medical devices, pharmaceutical and packaging. The role of Regulatory Affairs Manager is a key contributor role offering strategic advice for global submissions, particularly for the Emerging Markets.

The Role:

  • Manage regulatory agency communication to expedite approvals.
  • Product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
  • Ensuring timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
  • Support CMC regulatory activities for pipeline products.
  • Ensure that Marketing Authorisations are maintained and renewed.

Your Skills:

  • Experience in the preparation and maintenance of CMC components for regulatory submissions.
  • Solid understanding in developing Regulatory requirements, such as IDMP, XEVMPD for Regulatory Product data tracking, registration, eCTD for Publishing, SPL for Labelling IT Solutions.
  • Thorough understanding of FDA (21CFR 210, 211, 820 and EU regulations.
  • BSc / Master’s degree in Life Sciences or other science / engineering related discipline.

The Package:

As Regulatory Affairs Manager you’ll receive a highly competitive salary, up to 15% pension, annual bonus and relocation assistance.

To Apply:

To apply for this role, please click Apply button, or contact Gareth Wrigley at Pulse Engineering Solutions. All applications are received in the strictest confidence.

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