Officer - Regulatory affairs
Job Description
Title: Officer - Regulatory affairs
Company Name: A Reputed Pharmaceutical Company
Vacancy: 01
Age: 24 to 28 years
Location: Dhaka
Salary: Negotiable
Experience:
∎ 1 to 2 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies
∎ Freshers are also encouraged to apply.
Published: 2 Jul 2025
Education:
∎ Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm)
Requirements:
Additional Requirements:
∎ Age 24 to 28 years
Responsibilities & Context:
∎ 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.
∎ 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.
Compensation & Other Benefits:
∎ T/A, Mobile bill, Provident fund, Insurance
∎ Lunch Facilities: Partially Subsidize
∎ Salary Review: Yearly
∎ Festival Bonus: 2
∎ LTA and 2 alternative holiday on Saturday.
Workplace:
∎ Work at office
Employment Status: Full Time
Job Location: Dhaka
Company Information:
∎ A Reputed Pharmaceutical Company
Read Before Apply: Please apply only who are fulfilling all the requirements of this job
Application Deadline: 20 Jul 2025
Category: Others
