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Senior Regulatory Affairs Manager

1 week ago

Manila, National Capital Region, Philippines F. Hoffmann-La Roche Gruppe Full time
About the Opportunity

We are seeking a highly skilled and experienced Senior Regulatory Affairs Manager to join our team. In this role, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations.

Your key responsibilities will include:

  • Preparing high-quality CMC regulatory documents in accordance with Roche corporate standards and applicable health authority requirements.
  • Managing regulatory aspects of change control and ensuring timely communication to stakeholders regarding management of technical changes.
  • Interacting with regulatory agencies on defined matters.
  • Providing regulatory support for relevant quality systems, including change control, discrepancy management, and Health Authority inspection support.
  • Contributing to regulatory excellence by identifying opportunities, mitigating risks, and supporting continuous improvement.

Requirements

To be successful in this role, you will need:

  • A Master's Degree in life science disciplines or related field.
  • At least 3 years' experience in the pharmaceutical, biotechnology, or related industry in CMC, Regulatory, Quality, R&D, or Manufacturing.
  • Experience generating technical registration dossiers for China, EU, or USA is preferred.

Key Skills and Qualifications

The ideal candidate will possess:

  • Knowledge of regulations and guidelines in China and other major markets.
  • Proficiency with a wide range of data/information (CMC, clinical, non-clinical).
  • Strategic agility and proficiency in business tools, project management, and risk-management principles.