Purpose
The position is for workingon product registrations for Canada marketincluding compiling dossiers, answering queries from regulatory agencies, liaising with the cross-
functional teams to obtainneedful documents forproduct registration.
Position / JobTitleExecutive
DepartmentRegulatory Affairs
Reporting ToManager, Regulatory Affairs
LocationThane
Years of Experience
5-8years
Dosage Form
Anydosage form
Job Responsibilities
/ Deliverables
- Preparing andsubmitting regulatory dossiers in Canada including ANDS or NDS.
- Liaising with the cross-functional teamsfor documents for registration and reviewing them.
- Addressing and submitting any queries or deficiencies from the regulatory agencies or partners and ensuring product registration in the shortest time.
- Preparing and submitting pre-submission meetings to Health Canada.
- Ensuring the dossiers are submitted andregistered as per the schedule.
Qualifications & Pre- Requisites
- Experience in regulatory filingsin Canada
- Should be an M.Pharm/M.Sc
- Good communication andplanning skills.
Additional notes
- Will need to work in different shifts.
