Title: Officer - Regulatory Affairs
Company Name: A Reputed Pharmaceutical Company
Vacancy: 01
Age: 24 to 28 years
Job Location: Dhaka
Salary: Negotiable
Experience:
To ensure online application in BEZA database and follow up with authority to get import permission/block list for RM/PM.
To ensure documents endorsement from BEZA to release customs for RM/PM.
To ensure BEZA others activities (Trade license renewal, Environment certificate renewal, MoHA Security Clearance, Work permit, Visa Recommendation)
Liaise with BSTI, BCSIR , Atomic energy commission, Food safety authority ( Other than allopathic product Registration, Renewal & relevant coordination)
Liaise with Department of Narcotics Control (New product registration, license renewal, allocation recommendation & relevant activities)
To ensure Pharmacovigilance monthly report for DGDA & Corporate PV team.
To ensure Pharmacovigilance others activity (SOP updating, Complaint handling, New employee’s Training, archive, Literature review)
Liaise with Plant, commercial and others department to collect necessary documents for application.
To review the documents for different application for old site as per drug authority guidelines (Dossier evaluation docs, Registration Docs, Price Application docs, MA docs).
Manage the activities of Regulatory Affairs like preparation, co-ordination and following up of the necessary documentation and/or supplements needed for regulatory agency submissions.
LTA and 2 alternative holiday on Saturday.