Head of Global Regulatory Affairs (API Unit)

Role & responsibilities

The ACME Laboratories Limited, one of the top ranked and publicly listed pharmaceutical companies of the country enjoying significant coverage in domestic and international market. To cope up with the business growth and to accommodate business requirements, we are looking for competent, enthusiastic, energetic, innovative, qualified and responsible professional for our API Unit as Head of Global Regulatory Affairs.

Job Nature

Contractual (initially for two years, which can be extended based on both parties mutual understanding).

Job Location

BISCIC API Industrial Park, Gajaria, Munshiganj, Bangladesh. 45 Kms south of Dhaka.

Job Summary

Overall responsibilities for all activities of Global Regulatory Affairs.

Reports to

Director, API Unit.

Core Responsibilities

• Manage and ensure timely submission of product registration applications, dossiers, and related regulatory documents for local and international markets in compliance with applicable country-specific guidelines.
• Prepare and review clear regulatory arguments, justifications, and responses for new product registrations, renewals, and variations.
• Ensure timely submission of license variations, renewals, and other regulatory applications to maintain valid marketing authorizations.
• Manage assigned regulatory projects for stringent regulatory authorities, including US-FDA, WHO, TGA, EU, and UK-MHRA, in coordination with cross-functional teams and external consultants.
• Coordinate and support regulatory inspections, facility registration/renewal, and product approval activities, including effective communication and negotiation with regulatory authorities.
• Review existing company practices and recommend necessary improvements to ensure compliance with current regulatory requirements and guidelines.
• Coordinate and ensure the preparation and submission of regulatory documents for site/facility and product registration, renewal, and variation activities as required by respective authorities.
• Provide guidance and training to relevant departmental and cross-functional teams on applicable regulatory requirements, including ICH, WHO, GMP, GCP, stability, validation, and other international regulatory guidelines.
• Develop and implement modern tools, systems, and work processes to improve regulatory efficiency, reduce processing time, and enhance productivity.
• Perform any other regulatory affairs duties assigned by the supervisor related to product or facility registration, renewal, variation, and regulatory compliance.

Preferred candidate profile

Required Skills & Knowledge

• Adequate knowledge on regulatory guidelines including ICH, US-FDA, UK-MHRA, EU pharmaceutical legislation, WHO, DGDA guidelines, sound Knowledge on Microsoft MS Office (MS Word, PowerPoint, Excel etc.), should have good communication in English language (Both Oral & Written)
• Knowledge on GXP- cGMP, GLP, GDP etc., Analytical activities, Various raw data revision, General knowledge on manufacturing process and process control.

Required Qualification & Competencies

• M. Pharm / Post-Graduation in Biological Science or Chemistry or equivalent from any recognized university.
• MBA or relevant professional certification in relevant field will be an added advantage.
• Exceptional problem-solving and analytical abilities, with a systematic approach to decision-making.
• Coordination with Production, Quality Control, Warehouse, Engineering & R&D to ensure cGMP in the Plant.

Required Experience

• Minimum 15 years of experience in handing big API (multi-purpose) facilities.
• Proven experience in Global Regulatory Affairs roles within the API Industry, with strong experience in a leadership position.
• Proven track record in successfully managing regulatory inspections and audits of stringent regulatory authorities (e.g., US FDA, UK MHRA, EU, TGA, PMDA etc.).

Salary & Benefits

• Competitive & negotiable depending on individuals competencies (to be paid in USD or equivalent amount in local currency i.e., BDT).
• Full time car facility including fuel, maintenance and driver.
• Health insurance and Group Life Insurance coverage as per company policy.
• 2 (two) times return Air Ticket per year with 2 weeks paid holiday each time.
• Yearly performance bonus and salary review based on performance.
• Mobile phone facility.

Application Procedure

Candidate should be willing to relocate to Bangladesh and meeting all the requirements are highly encourage to apply by sending their updated resume mentioning “Head of Global Regulatory Affairs, API Unit” in the email subject line at [email protected] on or before August 20, 2026 (Thu).