Executive, Regulatory Affairs

Job Description

Title: Executive, Regulatory Affairs

Company Name: DBL Pharmaceuticals Ltd.

Vacancy: --

Age: At least 22 years

Job Location: Dhaka (Gulshan)

Salary: --

Experience:

• At least 1 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Bachelor of Pharmacy (B.Pharm)
• Bachelor of Science (BSc)

• At least 1 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Age At least 22 years

• Proficient in the Microsoft Office suite.

• Ensuring Company`s products comply with the regulations of the Directorate General of Drug Administration (DGDA), Bangladesh.
• Assisting submissions of new product registration and its renewal.
• Setting timelines for license variations and renewal approval.
• Assisting in undertaking and managing regulatory inspections.
• Preparing drug clearance for raw material & finished product which release from port.
• Negotiating with regulatory authorities for maintaining smooth business function.
• Specifying advertisement, labeling, product promotional material (PPM) and packaging requirements which approved by DGDA.
• Preparing submissions of NOC (No Objection Certificate).
• Negotiating with regulatory authorities about product price for marketing the product.
• Ensuring Company`s products comply with the regulations of the Department of Narcotics Control (DNC), Bangladesh.
• Ensuring Company`s products comply with the regulations of the Bangladesh Standard and Testing Institution (BSTI), Bangladesh.
• Ensuring Company`s license comply with regulations of the BERC, Department of Environment and other government authority.