Asia Pacific Regulatory Lead

3 days ago


Indiana, Pennsylvania, United States Jobleads-US Full time
About Our Team

We are a global healthcare leader seeking an experienced CMC regulatory expert to join our team in the Asia Pacific region. The successful candidate will provide strategic, tactical, and operational direction to expedite CMC development of Lilly's portfolio in the APAC region.

Job Description

This role requires a strong working knowledge of global regulations, guidelines, and regulatory precedence coupled with technical knowledge of development and manufacturing processes. The ideal candidate will have prior experience authoring CMC submission content and a proven track record of influencing business units, M&Q, and GRA leadership on regulatory positions.

Key Responsibilities
  • Evaluates regulatory impact of proposed CMC development plans and post-approval change agendas.
  • Develops relationships with personnel in other Lilly functional areas that promote open discussion of issues with a demonstrated ability to influence drug development strategies.
  • Coordinates preparation, review, and finalization of CMC documents for registrations and response to questions in AP region.
Requirements
  • Prior experience authoring CMC submission content.
  • Prior Regulatory CMC experience (4-7 years) or equivalent combination of technical and regulatory guidance knowledge.
  • Fluency in English and AP-regional language(s).


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