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CMC Process Development Manager

1 week ago

Cork, Cork, Ireland Hobson Prior Full time

Job Summary:

Hobson Prior is seeking a seasoned Senior Science Advisor to lead our Global Regulatory Affairs team.

The ideal candidate will have extensive experience in CMC process development and a strong understanding of regulatory guidelines and compliance regulations.

About the Role:

  • Provide strategic and operational guidance for CMC process development
  • Oversee the preparation and documentation of submissions
  • Lead and direct regulative activities
  • Review and approve changes, deviations, and proposals related to regulatory processes

Responsibilities:

  • Develop and implement effective regulatory strategies
  • Ensure compliance with regulatory guidelines and regulations
  • Collaborate with cross-functional teams to achieve business objectives

Requirements:

  • Proven track record in CMC process development and regulatory affairs
  • Strong understanding of regulative and compliance guidelines in pharmaceutical or biopharmaceutical manufacturing
  • Degree in a science-related field such as chemistry, biology, biochemistry, or pharmacy