Sr. RA Manager - CMC
Your tasks and responsibilities
• Responsible for planning and preparing the regulatory CMC strategy for assigned projects (both marketed and new products)
• Independently responsible for regulatory activities and CMC strategy implementation for assigned projects (both marketed and new products)
• Early identify potential CMC risks and propose the solutions for assigned projects and be able to influence the HAs' decisions.
• Serve as a primary contact person with HAs for assigned products/projects CMC technical reviewing.
• Build a good working relationship with HAs and academic association
• Responsible for internal communication for assigned products/projects and represents China RA CMC position and influence by given insight and technical input to drive achievable results, including both local quality, supply chain and global functions
• Manage people to take the responsibility for the assigned projects and give guidance to subordinates if applicable
• Ensure the compliance of Company internal Policy/ system/
database/ responsible projects and local regulation compliant
Should be able to foresee potential risks of compliance, especially from CMC perspective.
• Advanced technical degree (Ph.D., D.V.M. or Pharm.D. in life sciences with 6 years of regulatory experience
• MS with 8 years of regulatory experience
• BS with 10 years of regulatory experience
• In-depth knowledge of regional HA regulations to support filings. Some familiarity with global regulations.
• Knowledge and experience in drug development (manufacture, quality control, analytical, CTD, ICH guideline, GMP, QBD, etc.)
• A thorough knowledge of company policies and procedures in drug development and product maintenance requirements
• The position requires scientific and technical expertise, including the ability to develop robust CMC regulatory plans coveringall phases of drug development
• Excellent communication skills, verbal and written, are required
• Demonstrated ability to influence in a team environment
• The ability to work within a global team framework and a multi-cultural environment is required
• Strong analytical skills are required
• Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills
• Must have the ability to organize and direct diverse activities in a changing environment often under time pressure.
• Demonstrated problem solving as applied to local regulatory issues