Registered A-Grade Pharmacist
PCB Reg. No. A-18855
Kabbo
Saha.
Bridging pharmaceutical regulations and clinical expertise to support the development, approval, and accessibility of quality medicines worldwide.
Contact me ↗
Current role
Senior Executive, International Marketing & Regulatory Affairs
ACI PLC · Gulshan, Dhaka
International Marketing Department (IMD) and International Regulatory Affairs (IRA). Product registration and marketing authorization lifecycle management across ASEAN, Asia Pacific, and Latin and Central America. Earlier, Clinical Pharmacist at an internationally accredited (NABH) tertiary-level hospital.
Areas of expertise
CTD & ACTD Dossiers
Preparation, review and submission of regulatory dossiers
Product Registration
New registrations, renewals and variations in international markets
Bioequivalence
BE protocol and report review, BTIF preparation and RLD selection
Marketing Authorization
Lifecycle management and responses to authority queries
Clinical Pharmacy
Prescription review, medication reconciliation and patient counselling
Medication Safety
Antimicrobial stewardship, interaction checking, dose optimization and pharmacovigilance activities
01 / About me
Registered A-Grade PharmacistPCB Reg. No. A-18855
Regulatory expert with a clinical pharmacy foundation.
I have worked on both sides of a medicine's journey. In regulatory affairs I help pharmaceutical products reach international markets. In hospital practice I helped patients use medicines safely. Today I bring both to international marketing and regulatory affairs at ACI PLC.
Getting products approved
I prepared and reviewed CTD and ACTD dossiers and country-specific variation dossiers for Asia-Pacific, Latin American and Central American markets, covering registration, renewal and variation.
- Bioequivalence support: protocol and report review, BTIF preparation and RLD selection
- Drug Master File (DMF) review and coordination with API manufacturers to resolve post-submission queries
- Site and product registration documents: SOPs, validation, stability and pharmacovigilance
- Training sessions on country-specific regulatory guidelines
Keeping patients safe
As a Clinical Pharmacist in an internationally accredited (NABH) tertiary-level hospital, I worked with physicians and nurses to promote rational, safe and effective medication use.
- Prescription review and dose optimization
- Antimicrobial stewardship and restricted antibiotic monitoring
- Drug-drug and drug-food interaction checking, and medication reconciliation
- Pharmacovigilance activities and patient counselling
Together, these two backgrounds let me see a medicine from both ends: how it is approved and how it is used. I am a quick learner and a team player, and I communicate clearly in writing and in speech.
02 / Experience
Marketing, regulatory affairs and hospital pharmacy.
Senior Executive, International Marketing & Regulatory Affairs
ACI PLC, Gulshan, Dhaka, Bangladesh · Full-time, on-site
Working in the International Marketing Department (IMD) and International Regulatory Affairs (IRA).
International Marketing Department (IMD)
- Support international business development and product launches across ASEAN, Asia Pacific, and Latin and Central America.
- Coordinate with distributors and partners on product portfolios, registration status, and launch timelines.
- Work with cross-functional teams, including R&D, QA, QC, production, supply chain and others, so registered products reach markets on time.
- Track market and competitor information to support portfolio and product planning.
International Regulatory Affairs (IRA)
- Prepare, review and submit CTD, ACTD and country-specific dossiers for new registrations, renewals and variations.
- Manage the marketing authorization lifecycle, including responses to authority queries and regulatory change tracking.
- Support bioequivalence studies, DMF review and the documents needed for site and product registration.
- Keep up with country-specific regulatory guidelines and share updates with the team.
Executive, Global Regulatory Affairs
The ACME Laboratories Ltd., Dhaka, Bangladesh
- Prepared, reviewed, compiled and submitted CTD, ACTD and country-specific regulatory dossiers for new registrations, renewals and variations.
- Managed the marketing authorization lifecycle, including authority query responses, submission updates and regulatory change tracking.
- Coordinated and supported bioequivalence (BE) studies: clinical phase monitoring, protocol and report review, BTIF preparation and selection of Reference Listed Drugs (RLDs).
- Assessed regulatory requirements for product registration in Asia-Pacific, Latin American and Central American markets.
- Compiled and reviewed documents for site and product registration and renewal: SOPs, Drug Master Files (DMFs), validation, stability and pharmacovigilance documents.
- Reviewed the open part of DMFs and worked with API manufacturers to resolve post-submission regulatory queries.
- Delivered training and knowledge-sharing sessions on country-specific regulatory guidelines.
Executive (Clinical Pharmacist), Pharmacy
Labaid Cardiac & Specialized Hospital, Dhanmondi, Dhaka
- Reviewed and evaluated prescriptions, collaborating with physicians & nurses to optimize medication regimens and promote rational, safe, and effective medication use.
- Monitored restricted antibiotics, surgical antibiotic prophylaxis and concentrated electrolytes.
- Checked drug-drug and drug-food interactions, and performed medication reconciliation.
- Performed adverse drug reaction (ADR) detection, assessment, documentation and reporting in accordance with national pharmacovigilance guidelines.
- Handled Inpatient Department (IPD) activities, patient counselling, crash cart and floor stock maintenance.
- Provided drug information to patients and healthcare professionals.
The ACME Laboratories Ltd.
Topics covered: Production, Quality Assurance, Quality Control, Warehouse, Global Regulatory Affairs, Validation, R&D and Engineering.
03 / Education
Where I studied.
Master of Pharmacy (M.Pharm)
State University of Bangladesh
CGPA: 3.82 / 4.00
Bachelor of Pharmacy (B.Pharm, Hons.)
State University of Bangladesh
CGPA: 3.64 / 4.00
04 / Project and research
Comparative evaluation of aceclofenac tablets in Bangladesh.
Project report on the comparative evaluation of different brands of aceclofenac tablets available in Bangladesh, presented to the Department of Pharmacy, State University of Bangladesh. Supervisor: Prof. Dr. Md. Hassan Kawsar.
View my ResearchGate profile ↗05 / Skills
What I bring.
Professional
Computer
Interpersonal
06 / Certificates
Certificates, training and letters.
Tap a document to view it larger.
Good Clinical Practice
NIDA Clinical Trials Network. Six-hour course covering informed consent, participant safety, quality assurance, documentation and more.
ISO 9001:2015 Quality Management System (QMS)
Alison. CPD-certified online course on quality management systems. Verify online ↗
Cybersecurity Awareness Month
Cyber Crime Awareness Foundation. Certificate for taking part in the October 2023 campaign.
Training of Entrepreneurs (TOE)
SIYB Foundation of Bangladesh, under the Skills 21 Project, ILO-Dhaka. Modules: Generate Your Business Idea, Start Your Business and Green Business.
Certificate of Being Promising Leader
Youth Career Institute. In recognition of hard work and dedication in completing the project.
1st Asia Pacific Youth & Cultural Exchange Bangladesh Online 2021
Certificate of Participation. The event engaged youth in raising awareness on the Sustainable Development Goals and leadership.
Introduction to Digital Journalism
Reuters Training Course, sponsored by the Facebook Journalism Project. Certificate of Completion.
Experience and recommendation letters
Experience certificate
The ACME Laboratories Ltd. Executive, Global Regulatory Affairs, 1 October 2024 to 25 August 2026.
Recommendation letter
Labaid Cardiac & Specialized Hospital. Written by Md. Majedul Islam, Clinical Pharmacologist, for my work as Executive (Hospital Pharmacist).
Workshops
07 / Writer
90 files of my published writing
My articles, in one place.
I write features and columns for national newspapers in Bangladesh. This collection brings together my work from different papers.
Read my articles ↗Opens my article portfolio on Google Drive in a new tab.
08 / Awards
Awards and achievements.
1st Position, Theme Contest
Certificate of Achievement and winner's trophy for the logo design theme contest, State University of Bangladesh.
Host Batch, Theme Contest winner and Best Writer
Three trophies from the Department of Pharmacy, State University of Bangladesh: Host Batch, Theme Contest Winner and Best Writer (Award Show).
Honorary plaque as President
Bangladesh Tarun Column Lekhok Forum, Private University Unit, in recognition of my term as President for 2023–24.
Academic scholarship
Awarded once during my B.Pharm (Hons.)
09 / Convocation
Convocation 2025.
Moments from the 7th Convocation of State University of Bangladesh. Tap a photo to view it larger.
At the convocation
State University of Bangladesh, in my graduation gown.
On stage
Receiving my degree on stage at the convocation.
B.Pharm graduate
School of Pharmaceutical Sciences, Bachelor of Pharmacy.
10 / Activities
Writing, leadership and volunteering.
Writing and media
- Feature writer for Daily Prothom Alo, Daily Ittefaq, Daily Samakal, Channel 24 and others
- Column writer for national newspapers in Bangladesh
- Former Reporter cum Sub-Editor, Cyber Barta
Leadership
- President, Bangladesh Tarun Column Lekhok Forum, Private University Unit
- Advisor, SUB Pharmacy Club (SUBPC)
- Advisor, SUB Pharmacy Literature Society (SUBPLS)
- Former Student Ambassador, State University of Bangladesh
- Former Publicity Secretary, SUBPC
- Former Vice-President, Kaler Kantho Shuvosangho, SUB Unit
- Former Organizational Secretary, State University Journalist Association (SUJA)
Volunteering
- Organizational Committee Member, SUB 14th Pharma Week (2022)
- Coordinator of Volunteers, 6th Convocation 2022, State University of Bangladesh
- Research Assistant, Aachol Foundation
- Head of Private University Team, Bangladesh Career Olympiad
- Youth Ambassador 2021, Youth Career Institute
- Ambassador, Cyber Crime Awareness Foundation
- Member, Excellence Bangladesh and Smile Creator
- Central Coordinator, Icchepuron Manobik Foundation
Interests
11 / Contact
Get in touch.
LinkedIn ↗ Facebook ↗ ResearchGate ↗
Mohammadpur, Dhaka, Bangladesh. References are available on request.