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Senior Manager, Regulatory CMC

Hertfordshire   •  Permanent, Full time


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. Please quote reference 49970 in all correspondence.


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Stephanie Maccioni
  • Phone: 01438 743047
  • Reference: 49970
  • Updated: 25th March 2021
  • Expires: 22nd April 2021

CK Group

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