Sr. Executive/Executive-International Regulatory Affairs

Job Description

Title: Sr. Executive/Executive-International Regulatory Affairs

Company Name: A Renowned Pharmaceutical Company

Vacancy: --

Age: 24 to 30 years

Job Location: Dhaka

Salary: Negotiable

Experience:

• At most 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Master of Pharmacy (M.Pharm)

• At most 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Age 24 to 30 years

• Prepare and submit regulatory documents (CTD, ACTD, and country-specific dossiers) in compliance with respective country guidelines for new drug registrations and license renewals.

• Draft and submit timely responses to regulatory authorities’ queries on submitted dossiers (CTD/ACTD/country-specific) within stipulated deadlines.

• Review all dossiers (CTD/ACTD) prior to submission to ensure accuracy and compliance.

• Verify export packaging materials to maintain error-free text and regulatory conformity.

• Coordinate with relevant departments to collect supporting documents for dossier preparation and regulatory query responses.

• Inform cross-functional teams about regulatory updates, changes, or new guidance to ensure prompt implementation.

• Report customer complaints to the competent authority and the local regulatory body (DGDA) in a timely manner.

• Provident Fund

• Gratuity

• Festival Bonus:3

• Profit Share

• Weekly 2 Holidays

• Mobile Bill

• Group Life Insurance

• Lunch Facility: Partially Subsidized

• Salary Review: Yearly

• Pick & Drop Facility