Senior Manager, China CMC Regulatory Affairs
Takeda · Shanghai
Job Description
ACCOUNTABILITIES
- With minimal supervision, plans, executes and manages regulatory submission for assigned compounds in various phases of clinical development, marketing applications, and post -approval life cycle activities.
- As a RA CMC products leader or member, ensure and/or enhance regulatory compliance with respect to filling requirements for assigned compounds throughout development and the commercial life cycle.
· Independently prepare CMC submission dossier, define CMC content requirements, ensure high quality CMC submission complying with external and internal requirement.
· With moderate supervision, represent Takeda RA CMC Health Authority meetings and leads or supports CMC preparation activities for meeting with Health Authority on CMC relevant matters, interacts directly with Health Authorities, as required.
· With minimal supervision, handle sample registration testing in NIFDC/IDC, to support related registration approval.
· With moderate supervision, support Health Authority on-site inspection on CMC RA related matters.
· Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in professional and timely manner.
· Foster constructive working relationships when interacting with internal or external colleagues.
· Evaluates change proposals for regulatory impact. And plans global variations and amendments.
- Ensure compliance with all applicable Takeda SOPs, and local and international regulations.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
· BS/BA Degree required with 6+ years of relevant Industry, academic or HA experience; advanced degree preferred
· Experience with CMC regulatory and regulatory, or equivalent industry experience.
· Understanding of scientific principles and regulatory requirements relevant to drug development and post-market support.
· Proven ability to provide strategic regulatory guidance to drug development, registration and post market support teams.
· Able to deal with issue of critical importance with minimal supervision, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
· Demonstrated emerging leadership, problem-solving ability, flexibility and team work.
· Exercises good judgement in elevating and communicating actual or potential issues to line management.
· Excellent written and oral communication skills required.
· Active participation in Agency/ industry groups/forums preferred.