Regulatory Affairs Specialist

il y a 1 mois


Paris, Île-de-France ProductLife Group Temps plein

About the Job

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group in France. As a key member of our regulatory team, you will be responsible for ensuring compliance with local regulatory requirements and supporting the development of new products in China.

Responsibilities

  • Prepare registration files and respond to questions from regulatory authorities
  • Prepare clinical study authorization request files and ensure compliance with local regulations
  • Collaborate with the Chinese authorities on consultation requests and follow-up on variation and renewal files
  • Ensure that files are compliant with local regulatory requirements, including the Chinese pharmacopoeia and regulations on active ingredients, excipients, and packaging materials
  • Act as the primary point of contact for the subsidiary's regulatory team and the parent company's teams
  • Participate in the development strategy of new products in China, focusing on cardiovascular and oncology
  • Contribute to regulatory watch activities related to registration and development
  • Support industrial production transfer projects to China
  • Collaborate with the local regulatory team to ensure compliance with regulatory databases

Requirements

  • Life Sciences-related fields (Bachelor's or higher graduate degree in a science-related field)
  • Experience in RA in the Pharmaceutical Industry or Service Provider
  • Knowledge of EU/International registration, clinical trials authorization, and regulatory database management
  • Knowledge of China requirements is a plus

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