Regulatory Consultant Profile
MD. CHAND MIAH
Regulatory Consultant Lead | Regulatory Affairs Expert
28 Years of Experience in Pharmaceutical & Healthcare Regulatory Affairs
28+
Years of Experience
Regulatory Leadership
Across Top MNC3
Proven Track Record
In Regulatory Excellence
Profrssional Summary
MD. CHAND MIAH brings 28 years of dedicated experience in Drug Regulatory Affairs, built across a career with world-renowned multinational organizations under the Sanofi group — including Rhone-Poulenc, Fisons Bangladesh Ltd., Hoechst, Aventis, Sanofi-Aventis, Sanofi, and most recently as Country Regulatory Lead at Synovia Pharma PLC.
Over nearly three decades, he has served as the principal regulatory authority within these organizations, managing the full lifecycle of pharmaceutical, biological, and medical device regulation — from new product registration to post-approval compliance, pharmacovigilance oversight, and health authority liaison. His career reflects sustained, senior-level responsibility for regulatory strategy, team leadership, and direct engagement with Bangladesh's Directorate General of Drug Administration (DGDA).
Core Areas of Expertise
Regulatory Strategy & Leadership
Defining and validating national regulatory strategy for locally manufactured and imported pharmaceutical products, vaccines, and biosimilars.
Health Authority Liaison
Serving as the primary interface between organizations and the DGDA; building and sustaining trusted regulator relationships.
Product Registration & Submissions
Managing submissions for new chemical entities, generics, line extensions, new indications, food supplements, cosmetics, medical devices, and biosimilars.
Regulatory Compliance
Ensuring ongoing compliance of Marketing Authorizations, product packaging, labelling, and associated documentation with current licenses and regulations.
Risk Management
Coordinating health authority approval of Risk Management Plans (RMPs), DHPCs, and educational materials; overseeing regulatory risk assessment across product portfolios.
Pharmacovigilance Support
Providing regulatory input for batch/lot release of vaccines and biologics per local regulation.
Global-Local Coordination
Acting as the focal point between local operations and global regulatory affairs (GRA) functions of multinational partners.
Team Leadership & Development
Leading, mentoring, and building regulatory affairs teams; ensuring continuous professional development and readiness for evolving regulatory demands.
Trade Association Engagement
Active participation in local pharmaceutical trade bodies to help shape and respond to regulatory policy developments.
Extensive Experience
28 years in Drug Regulatory Affairs across leading multinational organizations.
Regulatory Authority
Principal regulatory authority with direct engagement with DGDA.
Proven Expertise
End-to-end regulatory expertise across diverse product portfolios.
Commitment to Excellence
Dedicated to compliance, patient safety and regulatory excellence.
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