Purpose
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 / JobTitleExecutive
DepartmentRegulatory Affairs
Reporting To
Sr.Manager, Regulatory Affairs
LocationThane
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.
