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


2020-12-05 01:00:27


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