R&D- Regulatory Supervisor- BJ
Sanofi Aventis
KEY ACCOUNTABILITIES:
· Support Line manager for implementing regulatory strategy to obtain the regulatory approval Support line Manager for the HA interaction for the strategy discussion and be accountable for the HA interaction to facilitate the implementation process Support line manager for regulatory intelligence collection and analysisPrepare for the registration submission and approval timelineFollow up QC testing timely and troubleshooting together with Global technical supportPrepare registration dossier and assure timely and high-quality submissionFollow up closely with registration procedure and assure proactive interaction with HA and give timely feedback once there is a queryEnsure all dossier and information kept on file based on company’s requirementsMaintain good relationship with officials and experts, both internal and externalJOB-HOLDER ENTRY REQUIREMENTS:
Education:
Master degree or above in Pharmacy, Medical, Biology or related field (Bachelor acceptable in special cases)Experience & knowledge:
2 years above in RA filed with recorded performanceCore competencies:
Good computer skill in EXCEL, POWERPOINT and WORD;Good interpersonal communication skill;English skill both in spoken and writtenPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
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