Regulatory Affairs Specialist for ProductLife Group

il y a 4 semaines


Paris, Île-de-France ProductLife Group Temps plein

About the Job

We are seeking a Regulatory Affairs Specialist to maintain ongoing exciting projects in France.

About us

ProductLife Group

Responsibilities

  • 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
  • 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

Education

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

Experience

Experience in RA in Pharmaceutical Industry or Service Provider

Skills

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


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