Executive, Regulatory Affairs & International Marketing

Job Description

Title: Executive, Regulatory Affairs & International Marketing

Company Name: A Renowned Pharmaceuticals Company

Vacancy: 1

Age: 25 to 33 years

Job Location: Dhaka

Salary: --

Experience:

• 2 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Tannery/Footwear, Group of Companies

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

• 2 to 3 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies, Tannery/Footwear, Group of Companies

• Age 25 to 33 years

• Good Business Negotiation, Excellent Presentation Skill, Leadership and Good Communication Skill, Proficient in MS Office Application

• Strategic & analytical skills

• Strong interpersonal & time management skills

• Must have fluency in English both of written & spoken, and also should have good computer literacy

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

• Submission of new medicines, and line extension dossiers according DGDA requirements.

• Completion of timeous registration and marketing authorization in line with business requirements in Bangladesh markets.

• Manage variations, renewals, and post-approval changes according to regulatory guidelines to ensure regulatory compliance.

• Obtaining the approval of new price and price increase of registered product.

• Prepare and obtain export-related documents (Form-10, COPP, FSC) approval from DGDA.

• Pursue and negotiating with regulatory authorities to obtain the NOC or registration of import medicines/medical device.

• Product sample submission to the DTL/NCL/DLS Lab, followed by completion of the required approval procedures.

• Assessing and revising the necessary document to approve the NOC for the import of Fish & livestock product/premix from DOF and DLS.

• Discuss and meet with the official to elucidate the NOC reviewing committee`s objection of DLS.

• Prepare and compile the necessary document, and it submission to obtain the License renewal from DLS & DOF.

• Arranging, carrying out, and managing inspections for license renewal of DLS & DOF.

• Pursue the Department of Narcotics Control, DoEX, BNACWC, DoE, BSTI, CCI&E, Boiler, BIDA, and BERC`s application, renewal, and compliance procedures for a variety of licenses and permits.

• Compile and submit country-specific dossiers, CTDs, and ACTDs in accordance with respective country for new drug registrations and renewals.

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

• Explore & develop the pharmaceutical export market. Formulate a business plan and carry it out for the intended export market.

• Assure the export market`s supply of promotional goods and pharmaceutical products.

• Keep updated with changes in local and global drug regulations.

• Travel Allowance

• Provident Fund

• Festival Bonus: 2

• Mobile bill

• Lunch Facilities: Partially Subsidize

• Salary Review: Yearly