Regulatory Affairs Specialist 365

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

• 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

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

• Experience in RA in Pharmaceutical Industry or Service Provider