This role is responsible for registration/notification and regulatory activities with the supervision from line manager, and assist to regulatory project when necessary.
To be responsible for the notification general work with supervision from liner manager, including all submission actives, regulatory input according to business requirement, etc.
To be responsible of notification document preparation for registration general work to make sure these materials comply with internal SOPs and external regulation, and complete notification within targeted timeline.
To communicate with authorizes, agencies if necessary to guarantee all regulatory activities fully comply with China regulations and requirement.
Good documentation for all registration materials
To be responsible for administration tasks for RA team.
Support line manager on other business requirement and regulatory projects
Bachelor degree or above (Pharmacy, Medical, Chemical, Toxicology or other related education background)
Good oral & written English language skill
Patient and willing to go to details
Able to work under time pressure and good project management skill