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- Regulatory Affairs CMC – Manager
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Regulatory Affairs CMC – Manager
Parexel International Corporation
Beijing, Beijing Municipality, China
Responsibilities:
1. Regulatory Filing and Strategy
Provide expertise in the development, communication, and implementation of China CMC regulatory strategies in support of China Regulatory CMC Head
Ensure regulatory CMC documents required for CTAs, MAs and Post approval variation submission, are developed with high quality and delivered in a timely manner, e.g. briefing documents, proof reading, etc.
Lead/coordinate cross-functional teams in development and submission of CMC documents, including responses to questions from regulatory authorities
Prepare for and participate in CMC-related agency interactions
2. Regulatory Intelligence
Monitor, assess and implement China CMC regulatory requirements
Review and assess CMC impact of health authority decisions for competitive products
Generate and communicate CMC intelligence to China regulatory CMC head
Monitor, assess and implement ChP policy and requirements
3. Collaboration
Provide regulatory CMC risk assessment to China regulatory filing teams
Escalate CMC issues, progress, and metrics to China regulatory CMC head
QualificationsBasic Qualifications:
Doctorate degree & 5 years of Regulatory and/or Compliance experience
OR
Master’s degree & 8 years of Regulatory and/or Compliance experience
OR
Bachelor’s degree or & 10 years of Regulatory and/or Compliance experience
Good communication skill on both oral and written, both in Chinese and English.
Preferred Qualifications:
China regulatory CMC knowledge and submissions experience, as well as ChP compliance knowledge and experience
Experience with health authority interactions
Working with policies, procedures and SOPs
Ability to understand and communicate scientific information
Ability to anticipate and prevent potential issues
Ability to communicate regulatory requirements to ensure expectations are understood
Competent with Microsoft Outlook/ Word/ Excel/Power Point/Project
Job posted: 2020-12-05