Officer, Regulatory Affairs (Local)

Job Description

Title: Officer, Regulatory Affairs (Local)

Company Name: US FDA Approved Leading Pharmaceuticals Company

Vacancy: --

Age: at most 35 years

Location: Dhaka

Salary: Negotiable

Experience:
∎ 2 to 3 years
∎ The applicants should have experience in the following business area(s):Pharmaceutical/Medicine Companies, Healthcare/Lifestyle product

Published: 12 Oct 2024

Education:
∎ Minimum B.Pharm from reputed university.

Requirements:

Additional Requirements:
∎ Age at most 35 years
∎ Ability to generate creative ideas and work under pressure.
∎ Collaborative team focus and ability to lead and inspire across departments.
∎ Excellent verbal, written and presentation skills.
∎ Excellent computer skills.
∎ Strong communication skill.
∎ Ability to generate creative ideas and work under pressure.
∎ Collaborative team focus and ability to lead and inspire across departments.
∎ Excellent verbal, written and presentation skills.
∎ Excellent computer skills.
∎ Strong communication skill.

Responsibilities & Context:
∎ Arranging and Coordinating Manufacturing License Approval/Renewal & Product Renewal from DGDA.
∎ Arranging and Coordinating New Product Registration from DGDA.
∎ Arranging and Coordinating Product Sample test report from DGDA Drug Testing Lab (DTL).
∎ Arranging and Coordinating Price approval of New product & Revised price approval of existing products from DGDA.
∎ Arranging and Coordinating Export related Certificates from DGDA (GMP, CPP, FSC, NOC etc.)
∎ Arranging various product related amendments & Changes from DGDA.
∎ Coordinating various Regulatory and approval related issues with BSTI, Trademark (DPDT), BE Center, BMRC, Depot Licenses etc.
∎ Facilitating and Coordinating various regulatory inspections.
∎ Keeping continuous coordination with relevant Departments (Marketing, International Marketing, Pharmacovigilance, R&D, QA, Procurement, IRA, Accounts etc.).
∎ Arranging and Coordinating Manufacturing License Approval/Renewal & Product Renewal from DGDA.
∎ Arranging and Coordinating New Product Registration from DGDA.
∎ Arranging and Coordinating Product Sample test report from DGDA Drug Testing Lab (DTL).
∎ Arranging and Coordinating Price approval of New product & Revised price approval of existing products from DGDA.
∎ Arranging and Coordinating Export related Certificates from DGDA (GMP, CPP, FSC, NOC etc.)
∎ Arranging various product related amendments & Changes from DGDA.
∎ Coordinating various Regulatory and approval related issues with BSTI, Trademark (DPDT), BE Center, BMRC, Depot Licenses etc.
∎ Facilitating and Coordinating various regulatory inspections.
∎ Keeping continuous coordination with relevant Departments (Marketing, International Marketing, Pharmacovigilance, R&D, QA, Procurement, IRA, Accounts etc.).

Workplace:
∎ Work at office

Employment Status: Full Time

Job Location: Dhaka

Company Information:
∎ US FDA Approved Leading Pharmaceuticals Company

Read Before Apply: Please apply only who are fulfilling all the requirements of this job

Application Deadline: 20 Oct 2024

Category: Others