About the job

To maintain ongoing exciting projects, we are urgently looking for a Regulatory Affairs Specialist to join our teams in France.

About us

Group 10

  • Preparation of registration files and answers to questions from the authorities
  • Preparation of clinical study authorization request files
  • Preparation of consultation requests with the Chinese authorities
  • Follow-up of variation and renewal files with the dedicated subcontracting platform
  • Ensure compliance of files with local regulatory requirements (e.g., Chinese pharmacopoeia, regulations on active ingredients, excipients, packaging material) with animation of a multidisciplinary working group
  • To be the privileged interlocutor of the teams of the subsidiary, in particular regulatory, and of the teams of the parent company
  • Participation in the development strategy of new products in China mainly in cardiovascular and oncology
  • Participation with the local regulatory team in regulatory watch activities related to registration and development
  • Participation in industrial production transfer projects to China
  • Be a member of specific China Core Teams, Study Teams when necessary
  • Contribution to compliance with in particular monitoring of the real-time update of regulatory databases

Group 11

  • Life Sciences related fields (Bachelor’s or higher graduate degree in a science related field)

Group 12

  • Experience in RA in Pharmaceutical Industry or Service Provider

Group 13

  • Knowledge of EU / International registration (Preparation of registration files, ATQs, variations, renewals management)
  • Clinical Trials Authorization (CTA) knowledge
  • Regulatory Database knowledge
  • Knowledge of China requirement is a plus

Regulatory Affairs Specialist 365