1 Regulatory Affairs Manager • Assist RA Director to propose/develop, implement, review and update registration/regulatory affairs strategy plan, manage and supervise the team to ensure product registration and perform regulatory affair activities under policies and standard operating procedures(SOP), and other applicable laws and regulations.
• Oversee the progress and ensure key projects registration approval. Provide proposal to RA director about strategy and **** plan of these key projects and implement accordingly. Timely communication with other functions about the projects progress.
• Preliminary review and approve part of registration dossier and other regulatory documents (e.g., local physician circular, packaging components, application letter or appeal letter) to ensure the content is correct.
• Manage overall progress of key projects through project meetings. Coordinate internal departments in product registration process.
• Communicate with regulatory agencies/institutes (e.g., SFDA, CDE, NICPBP, Coast Drug Control Institutes) on product registration, including but not limited to regulatory inquiries, sample testing
• Provide guidance and support to Registration Staff in problem solving and making recommendation on common technical or registration procedure issues
• Participate in regulatory affairs activities assigned
• Cross Functional
-Provide input to the new product launch activity if necessary
-Provide input from regulatory point of view to ensure market supply import complying with local regulation. Regulatory Affairs Director
Regulatory Affairs Supervisor
Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
• Bachelor Degree in any life science discipline or the equivalent
• 5-7 years experience in pharmaceutical industry
• Good knowledge of relevant laws, regulations and guidelines
• Good command of both written and spoken English and Chinese/Mandarin
• Self-initiated individual with good communication and interpersonal skills
• Proficiency in using MS Office Applications
Role related Performance Indicators:
• People management efficiency
• Social Network efficiency
• Project management efficiency
• Team productivity & efficiency
Role related Competencies
(Behavioural Indicators)
• Judgment
• Support of Diversity
• Job Knowledge/Technical Knowledge
• Problem Solving
• Staff development
• Business Engagement
• Strategic Thinking
• Values and Ethics
• Resource Management

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