Executive

Job Description

The position is for working on product registrations for US market including compiling dossiers, answering queries from regulatory agencies, liaising with the cross-functional

teams to obtain needful documents for product registration.

Sr.Manager, Regulatory Affairs

5-8years

Anydosage form

• Preparing and submitting regulatory dossiers in the US including ANDA and NDA.
• Liaising with the cross-functional teams for documents for registration and reviewing them.
• Addressing and submitting any queries or deficiencies from the regulatory agency and ensuring product registration in the shortest time.
• Preparing and submitting pre-ANDA, pre-IND, pre-NDA meeting request and briefing packages to USFDA.
• Ensuring the dossiers are submitted and registered as per the schedule.

• Experience in regulatory filings with USFDA preferably in complex products and drug device combination products.
• Should be an M.Pharm/M.Sc
• Good communication and planning skills.

• Will need to work in different shifts.

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