Sr.Executive- Regulatory Affairs-Biologics (Mumbai)

Sr.Executive- Regulatory Affairs-Biologics (Mumbai)

30 Jul
|
Talental Consultings
|
Mumbai

30 Jul

Talental Consultings

Mumbai

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:*

- eCTD, CTD, Validation, ICH requirements, USFDA Filings,

- WHO Prequalification, MCC South Africa for Biological and

- Biotech products

- Has exposure to in-licensed dossier filing and out licensin

📌 Sr.Executive- Regulatory Affairs-Biologics (Mumbai)
🏢 Talental Consultings
📍 Mumbai

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