Hybrid Regulatory CMC Manager, Regulatory Consulting

Posted 2 days ago

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About the role

  • Regulatory CMC Manager supporting multi-product global regulatory CMC for products at Marketing Authorisation Application Stage. Focused on documentation preparation, submissions, and providing regulatory support.

Responsibilities

  • Support the execution of multi-product global regulatory CMC for products at Marketing Authorisation Application Stage
  • Contribute to the preparation and submission of regulatory CMC documentation
  • Provide regulatory support to various cross-functional teams
  • Contribute to strategic Regulatory CMC discussions

Requirements

  • Experienced CMC Regulatory Manager
  • Authoring of CMC sections for Marketing Authorisations dossiers
  • Reviewing CMC sections of regulatory submissions
  • Working with regulatory colleagues in development of global regulatory CMC strategies and submissions
  • Participating on cross-functional teams and serving as the primary regulatory CMC contact for assigned products and projects

Benefits

  • Career development and progression
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition and total rewards program

Job title

Regulatory CMC Manager, Regulatory Consulting

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

No Education Requirement

Location requirements

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