The Regulatory Affairs Country associate will report to Regulatory Affairs Head Tunisia Libya.
The Regulatory Affairs Country associate will be responsible of managing the regulatory strategy (ie: MA Registration) and the post-approval changes dossier to Health Authorities in line with local regulations and planning set up by Global/Regional BU/Country regulatory team.
Specific requirements and responsibilities include:
and /or preparing any type of response documents to the Health Authorities questions by interacting with the relevant stakeholders (BU region regulatory, GRA, RSO local medical, local Pharmacovigilance department etc.).
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