SR.)MANAGER, CMC REGULATORY AFFAIR, R&D, SHANGHAI/BEIJING

Job Description RESPONSIBILITIES.
Develop and execute global regulatory strategies for assigned programs Collaborate with regional counterparts to compile and align global regulatory strategies Create and submit high-quality, compliant regulatory documents within defined timelines Manage regulatory submissions and maintain compliance for assigned programs Support health authority interactions and meetings related to assigned programs Ensure accurate, up-to-date reporting of program status and milestones globally Lead and mentor junior staff, enhancing team capabilities R&D Qualifications & Skills Expertise in developing regulatory strategies and a deep understanding of CMC requirements Proven ability to negotiate with and influence health authorities Strong leadership skills, capable of managing and directing project teams Effective at working across functions to align strategies and achieve objectives Skilled in managing regulatory submissions and maintaining compliance Excellent communication skills, able to clearly convey complex information Proficient in mentoring and developing junior staff, enhancing team capabilities Capable of identifying and mitigating risks in regulatory strategies and operations