Regulatory Affairs Cmc Manager

Novartis UK

Unknown, United Kingdom
Global cmc regulatory strategy formulation
Health authority submission documentation
Cmc risk management assessment preparation
The role is responsible for formulating and leading global CMC regulatory strategy to maximize business benefit while ensuring compliance

Job Summary

  • The role is responsible for formulating and leading global CMC regulatory strategy to maximize business benefit while ensuring compliance.
  • Candidates must lead all global CMC submission activities including planning, authoring, reviewing, and coordinating technical source documents.
  • The position requires initiating and leading interactions with Health Authorities to support new product or post-marketed launches.

Matching Summary

The role is responsible for formulating and leading global CMC regulatory strategy to maximize business benefit while ensuring compliance.

Skills & Requirements

Must-have

  • Global CMC regulatory strategy formulation
  • Health Authority submission documentation
  • CMC risk management assessment preparation
  • Cross-functional team collaboration
  • Regulatory compliance adherence

Nice-to-have

  • Innovation focus in regulatory activities
  • Negotiation skills with Health Authorities
  • Experience with post-marketed launches
  • Strategic project presentation skills

Key Requirements

  • Cross-cultural experience required
  • Operations management and execution skills
  • Project management expertise needed

Work Rights

Not specified

Tailored Resume

Cover Letter