Senior Manager, Regulatory CMC

  • Salary: Competitive
  • REF Number: 00049650
  • Consultant: Andy Leake
  • Contact: 01438 842 966
  • Date Published: 18.01.2021
  • Sector: Non-Specific
  • Location: Hatfield, Home Counties, South East
  • Discipline: Regulatory Affairs

CK Clinical are recruiting for a Senior Manager, Regulatory CMC for a permanent role with a well-established and successful international pharmaceutical company based in Hatfield, Hertfordshire.

Senior Manager, CMC Role: To lead Regulatory CMC activities and to provide Regulatory CMC expertise to multiple global projects.

Key duties will include:

  • Leading and supporting multiple global projects.
  • Be accountable for execution of multiple projects and stakeholder's satisfaction.
  • Provide regulatory CMC advice to project members.
  • Lead preparation of regulatory CMC documents and Module 3 sections.
  • Working closely with IPT and CMC teams to advance development projects towards submission and approval.
  • Providing CMC support on established products including growth market submissions and post-approval activities.

Your Background: As Senior Manager, you will need:

  • At least a University Degree in a Scientific field
  • Extensive Regulatory CMC experience gained within a pharmaceutical company at Manager level.
  • Experience working with agencies/vendors.
  • Experience in the development of solid/parenteral dosage forms.
  • Ability to manage conflicting guidance and provide solutions.

Apply: Entitlement to work in the UK is essential. For more information or to apply for this Senior Manager, Regulatory CMC position, please contact Andy Leake on 01438 842966 or email aleake@ckgroup.co.uk. Please quote reference 49650 in all correspondence.

We'll store this in session so if you're applying for multiple jobs today so you can use this as a base.