Senior RA Specialist/RA Supervisor

• Independently perform and manage day-to-day product registration operations and ensure timely completion of the registration tasks assigned, in compliance with local applicable laws, regulations, guidelines, and policies and SOPs.

• Assist in the development of product registration strategy and action plan as well as regulatory affairs activities assigned.

• Compile registration dossier and prepare other regulatory documents (e.g. local physician circular, package insert, packaging components) and ensure that the data presented fully represents what is practically required and ensure timely regulatory submission upon internal review and approval.

• Communicate with regulatory agencies/institutes (e.g., NMPA, CDE, NIDC, Coast Drug Control Institute) on product registration.

• Timely/Closely follow up the review process and report any updates to Manager timely.

• Properly maintain all regulatory documentation.

• Collect internal/external regulatory and competitive information and report to Manager.

• Assist in RA tasks/activities assigned

• Review promotional and non-promotional materials according to local regulation and global procedures.

• Support the preparation of technical documentation / dossier for hospital enlisting, tender application, pricing submission, custom clearance, as applicable. • Communication with HA during regulatory activities

Job Requirements:

• Bachelor Degree in any life science or the equivalent

• 1-5 years experience in pharmaceutical industry

• Good knowledge of relevant laws, regulations and guidelines

• Good command of both written and spoken English and Chinese/Mandarin

• Self-initiated individual with good communication and interpersonal skills

• Proficiency in using MS Office Applications