Senior Executive/ Junior Assistant Manager- International Regulatory Affairs

Job Description

Title: Senior Executive/ Junior Assistant Manager- International Regulatory Affairs

Company Name: Beacon Pharmaceuticals PLC

Vacancy: --

Age: Na

Job Location: Anywhere in Bangladesh, Dhaka

Salary: --

Experience:

• At least 4 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

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

• B. Pharm / M. Pharm from any reputed university

• At least 4 years
• The applicants should have experience in the following business area(s): Pharmaceutical/Medicine Companies

• Minimum 4 years of proven experience in International Regulatory Affairs, specifically in preparing and compiling CTD/ACTD dossiers.

• Strong understanding of country-specific regulatory requirements and dossier submission processes.

• Proficiency in MS Office with strong documentation accuracy and formatting skills.

• Ability to effectively follow up with regulatory authorities and coordinate with cross-functional departments.

• Good knowledge of ICH, WHO, and ASEAN guidelines, with strong attention to detail in reviewing regulatory documents.

• Strong communication, coordination, and time-management skills with the ability to work independently under pressure.

BEACON is one of the fastest growing pharmaceutical companies of Bangladesh. After the success in local market, Beacon is the most popular Bangladeshi company in global market for its high-tech oncology & hepatitis products.

BEACON Pharmaceuticals PLC is a vision-driven company and designed to conform to the Global standards like US FDA, UK MHRA, TGA Australia, WHO cGMP and has set up the dedicated oncology plant in Bangladesh with isolator technology to manufacture anticancer drugs.

To support and strengthen our existing team we are looking for smart, ambitious, energetic, intelligent and committed individuals for the following position:

Job Responsibilities

• Prepare regulatory dossiers in CTD/ ACTD format, or according to the specific regulatory requirements of different countries.

• Review, verify, and compile all dossier-related documents, ensuring completeness, accuracy, and compliance with respective regulatory guidelines.

• Follow up with regulatory authorities of various countries regarding queries, clarifications, deficiencies, or additional document requests.

• Monitor changes in global and country-specific regulatory requirements, interpret updates, and communicate these changes to the respective internal departments promptly.

• Maintain control and proper documentation of all regulatory and product registration-related documents, including certificates, ates, annexures, approvals, and correspondence.

• Perform any additional responsibilities assigned by the management from time to time in alignment with regulatory and compliance needs.

Job Location: Head Office & Factory

• Salary Range: Attractive remuneration package will be given to deserving candidate