Sr.Executive- Regulatory Affairs-Biologics

Position - Sr. Executive- Regulatory Affairs (biologics Division ) (biosimilar Products )
*Location -Mumbai* 

Roles and Responsibilities :

•  Preparation and reviewing of CTD and ACTD dossier.

• Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.

•  Co-ordination with plant for Regulatory compliances.

• Timely achievement of monthly plan & timely query response.

•  Gap Analysis/Updation of Master data.

• Get feedback from all the countries for respective variation, and their timely submission.

• renewals.

•  Master data Updating.

•  Follow ups with plant for documentation regularly and review meeting.

*skills:*

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