In the context of strengthening our team, we are looking for a Chinese speaker to work as a Regulatory Project Coordinator in Europe.

Group 10
Responsibilities

  • Organize the planning and monitoring of submission activities for given activities/projects
  • Provide regulatory support to clients and associate companies.
  • EU registrations and lifecycle maintenance experience
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.
  • Assisting with license applications as required.
  • Preparation and submission of documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II, BSVs, Renewals, PIQ, BROMI and MAH Transfers/COAs
  • To support the compiling of regulatory dossiers in accordance with national requirements.
  • Preparation and submission of Technical/Site Transfer Applications
  • Assisting with the preparation of EU Marketing Authorisation Applications
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
  • Ensuring compliance with national and European guidelines/legislation and regulations
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
  • Systems Management and Administration; Document and track regulatory submissions and regulatory authority approval.
  • Provide on-going regulatory support to the Regulatory Affairs Manager and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.

Group 13
Profile

  • Degree in life science discipline or Pharmacist background with 2-4 years relevant experience
  • Fluent in English and Chinese
  • Experience of promotional/non-promotional activities would be an advantage
  • Good IT skills/knowledge
  • Good organisational skills
  • Good communication skills
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritise different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work

Regulatory Project Coordinator 601