1) Draft product registration strategy plan for review and approval.
2) Compile registration dossier and prepare other regulatory documents and ensure timely regulatory submission upon internal review and approval.
3) Communicate with regulatory agencies/institutes (e.g. NMPA) on product registration, including but not limited to regulatory inquiries, review committee meetings, sample testing and standard writing.
4) Timely/closely monitor regulations and review process for ensuring the data presented fully represent what is practically required and the constantly changing regulations to be followed. Meet or accelerate regulatory milestones.
5) Properly maintain all regulatory documentation.
6) Perform ad hoc projects or assignments
7) Work closely to NMPA and testing center, establish and maintain good relationship.
8) Adapt to rapid changes in business environment, meet different requirements.
MINIMUM REQUIREMENTS
1) Master or above degree in life science , including but not limited to pharmaceutical, biological, medical sciences.
2) With 2-3 years experience in drug regulatory affairs or medical device regulatory affairs in pharmaceutical company. Import drug or medical device registration experience preferred.
3) Fluency in written and spoken English.
4) Proficiency in Excel and other MS Office tools.
5)Well-organize with strong sense of responsibility. Can work orderly and efficiently .
6) Excellent inter-personal, communication and presentation skill.
7) Be patient and earnest on product registration projects.
8) Good team player.
9) Independent handle project ability