Regulatory Affairs Specialist for ProductLife Group
il y a 4 semaines
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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