Executive /Senior Executive- Regulatory Affairs

Role & responsibilities:

• Preparation and Submission of the dossiers in CTD and ACTD, ECTD structure.
• Registration dossiers for Southeast Asia/ Africa/ South Africa / CIS / ROW Prequalification.
• Communication with manufacturing site for document requirement for dossier preparation.
• Collection, review and collating the data required for regulatory submissions.
• Arranging sample for registration from sites.
• Preparation of COPP/FSC etc. as per registration requirements.
• Handling the queries of the respective markets sent by local representatives OR the regulatory body of that country in guidance of respective managers.
• Checking Artworks as per the country specific requirements.
• Preparation of Package insert, SmPC, PIL of Generics with respect to Innovator information.
• Responding to request from Internal teams like marketing Domestic and International marketing.
• Maintaining tracker sheets for regulatory status (Registration, submission and targeted submission, etc) updated up to the date.

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