Rajib Kumar Baishnab
Dhaka,13
Summary
Experienced Global Regulatory Affairs Professional with a life sciences background and nearly 15 years of expertise in regulatory approval processes. Highly organized, detail-oriented, and proactive, with strong communication and problem-solving skills. Skilled in navigating complex regulatory landscapes, managing global submissions, ensuring compliance, and accelerating product approvals. Committed to driving regulatory excellence, supporting cross-functional collaboration, and enhancing operational efficiency to help organizations achieve their global market goals.
Overview
14
14
years of professional experience
Work History
Assistant General Manager
The ACME Laboratories Limited
01.2023 - Current
Assistant General Manager & Head of Global Regulatory Affairs
The ACME Laboratories Ltd.
05.2016 - Current
- Company Overview: www.acmeglobal.com
- Provide leadership and strategic direction to Regulatory Affairs Team, managing resources, delegating responsibilities, and ensuring the successful execution of regulatory projects aligned with organizational goals.
- Oversee the preparation, compilation, review, and submission of high-quality regulatory dossiers, including ANDAs, MAA, supplements, amendments, variations, renewals, annual reports, and responses to health authority inquiries, ensuring full regulatory compliance.
- Develop and implement robust regulatory strategies to support new product approvals, lifecycle management, and timely market entry across multiple international territories.
- Drive cross-functional collaboration with internal departments (R&D, QA, QC, Manufacturing, Pharmacovigilance) and external partners to facilitate seamless regulatory project execution.
- Maintain regulatory documentation databases and information management systems, ensuring adherence to global regulatory requirements, corporate SOPs, and data integrity standards.
- Successfully led product submission in eCTD-format to the U.S. FDA and other health authorities establishing new benchmarks for submission quality and compliance with evolving regulatory requirements.
- Monitor regulatory submissions under review, proactively address agency queries and deficiency letters in collaboration with internal and external stakeholders, and negotiate approvals to expedite product availability.
- Conduct regulatory assessments of change controls, ensuring compliance with applicable global regulations (FDA, ICH, 21 CFR) and providing strategic recommendations for implementation.
- Author, review, and finalize departmental Standard Operating Procedures (SOPs), promoting regulatory excellence, operational consistency, and continuous improvement.
- Stay abreast of evolving global regulatory landscapes, policies, and guidelines, delivering targeted regulatory intelligence updates and training to internal teams and external collaborators.
- Manage the complete lifecycle of regulatory submissions, including gap analysis, variations, renewals, amendments, and line extensions, ensuring regulatory compliance throughout product lifecycles.
- Facilitate effective communication with internal stakeholders, third-party manufacturers, and regulatory agencies to resolve bottlenecks, optimize submission timelines, and uphold regulatory and operational standards.
- Ensure the consistency, accuracy, and adequacy of all regulatory submissions, maintaining alignment with current regulatory expectations and best practices.
- Senior Manager (Grade –I), Global Regulatory Affairs
- Senior Manager (Grade-II), Global Regulatory Affairs
- Manager, Global Regulatory Affairs
Senior Executive, Global Regulatory Affairs
SQUARE Pharmaceuticals Ltd.
03.2011 - 05.2016
- Company Overview: www.squarepharma.com.bd
- Prepare, compile, and submit regulatory dossiers (ANDAs, ACTD, CTD formats) for the U.S., Europe, WHO, and numerous international markets, ensuring timely and accurate submissions.
- Recommend regulatory strategies and conduct due diligence across various stages of product development to support global registration objectives.
- Manage lifecycle activities for approved products, including submission of Annual Reports, Post-Approval Supplements (CBE-0, CBE-30, PAS), labeling updates, and FDA deficiency responses.
- Generate and submit Structured Product Labeling (SPL) for drug listings and manage communication with the U.S. FDA on regulatory queries.
- Analyze regulatory requirements across different export markets and provide updated regulatory intelligence to internal stakeholders for implementation.
- Review and validate technical documents including specifications, standard testing procedures, stability protocols, method and process validations, and drug master files (open part) to ensure regulatory compliance.
- Handle regulatory submissions and tender documentation for local, institutional, and international markets.
- Conduct retrospective, concurrent, and prospective process validations, ensuring compliance with GMP, ICH, WHO, EU, and country-specific regulatory guidelines.
- Support Quality Systems by handling Change Controls, Deviations, Risk Assessments, and monitoring the implementation of corrective and preventive actions (CAPAs).
- Perform routine and trial product analysis, sample management, and ensure adherence to Good Laboratory Practices (GLP) within the laboratory environment.
- Actively contribute to maintaining regulatory and quality compliance standards, supporting organizational readiness for inspections and audits.
- Senior Executive, Quality Compliance
- Executive, Quality Control
Education
MBA - International Business
University of Dhaka
04.2025
Master of Pharmacy - undefined
State University of Bangladesh
01.2012
Bachelor of Pharmacy - undefined
University of Science and technology Chittagong (USTC)
01.2008
Higher Secondary Certificate (H.S.C.) - undefined
Chittagong Cantonment College, Chittagong
Secondary School Certificate (S.S.C.) - undefined
Chittagong Govt. High School
Skills
- Global regulatory Affairs
- Project Management
- Regulatory Compliance
- Product Life Cycle Management
- CMC Writing & Review
- CTD Filing (Paper Submission)
- ECTD Filing (Electronic Submission)
- SOP & Workflow writing & review
- Liaisons with Regulatory Authorities
- Regulatory Audit Management
Languages
Read, write and speak: English, Bangla and Hindi
References
Naushad, Islam, Executive Director, Oncology Regulatory Strategy, Global Regulatory Affairs, naushad.islam@gmail.com, +1732-261-7694, Daiichi Sankyo, Inc., Basking Ridge, New Jersey, USA
Accomplishments
- Successfully led the development and submission of a Paragraph IV (Patent Challenge) ANDA, resulting in FDA approval and market entry of the product positioning the organization as a key player in the generic pharmaceutical market.
- Developed and executed comprehensive regulatory strategies for successful submission and approval of multiple Generic Products in US Market.
- Led and managed the regulatory approval process for a diarrheal disease drug product, ensuring compliance with WHO prequalification requirements. Coordinated and facilitated meetings with WHO officials, presenting the drug product's regulatory status and addressing any concerns or questions.
- Worked as a core team member of Quality Compliance Team of USFDA Audit to ensure compliance in all area as per USFDA 21 CFR part 210,211 and Part 11 guidelines and ensured zero 483 observations from USFDA.
- Supported QA as needed & ensured to achieve Global Regulatory accreditation from different stringent Regulatory Authority like UK-MHRA, TGA-Australia, SAHPRA-South Africa, WHO –Prequalification.
- Successfully submitted Dossier, handling all the queries & ensured timely registration of many products in different market i.e. US, UK, South Africa, Netherland, Ireland, Poland, Thailand, Peru, Malaysia, Vietnam, Turkey, Venezuela, Cambodia, Philippine etc.
Extra-Curricular
International Editorial Board member at International Journal of Drug Regulatory Affairs (IJDRA) Member of Regulatory Affairs Professional Society(RAPS), USA
Affiliations
- Registered Pharmacist at Bangladesh Pharmacy Council.
- Member of Regulatory Affairs Professional Society(RAPS), USA
- International Editorial Board member at International Journal of Drug Regulatory Affairs (IJDRA)
- International Editorial Board member at Indian Journals
Timeline
Assistant General Manager
The ACME Laboratories Limited
01.2023 - Current
Assistant General Manager & Head of Global Regulatory Affairs
The ACME Laboratories Ltd.
05.2016 - Current
Senior Executive, Global Regulatory Affairs
SQUARE Pharmaceuticals Ltd.
03.2011 - 05.2016
MBA - International Business
University of Dhaka
Master of Pharmacy - undefined
State University of Bangladesh
Bachelor of Pharmacy - undefined
University of Science and technology Chittagong (USTC)
Higher Secondary Certificate (H.S.C.) - undefined
Chittagong Cantonment College, Chittagong
Secondary School Certificate (S.S.C.) - undefined
Chittagong Govt. High School
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