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Job Description & How to Apply Below
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.
Position / Job Title Executive Department Regulatory Affairs Reporting To
Sr.Manager, Regulatory Affairs
Location Thane Years of Experience
5-8years
Dosage Form
Anydosage form
Job Responsibilities
/ Deliverables
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.
Qualifications &Pre
- Requisites
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.
Additional notes
Will need to work in different shifts.
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