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Rohan Mishra
Senior Executive – Regulatory Affairs
Senior Executive – Regulatory Affairs
Rohan Mishra is a Regulatory Affairs Specialist with over 13 years of experience in managing global product registrations, dossier submissions, and regulatory compliance for pharmaceutical formulations. He excels in compiling and reviewing CTD, ACTD, and country-specific dossiers for solid and injectable products, ensuring timely approvals and adherence to international standards. Skilled in cross-functional coordination, artwork review, and document control, Rohan effectively collaborates with QA, QC, and production teams to streamline regulatory operations. Committed to maintaining quality and compliance, he leverages his technical expertise to support successful market authorizations and lifecycle management across diverse geographies.
FORMERLY AT
Ratnamani Healthcare Pvt. Ltd.
LOCATION
Ahmedabad,India
AVAILABILITY
Full-time
Skills
ACTD
Country-Specific Dossiers
CTD
Document Management Systems
Dossier Compilation Tools
MS Office
Regulatory Documentation Systems
Regulatory Submissions (ROW Markets)
Work Experience
Senior Executive – Regulatory Affairs
Ratnamani Healthcare Pvt. Ltd.
June 2016 – Present
- Compile and review CTD/ACTD dossiers and registration files for solid and injectable products.
- Prepare regulatory documentation, declarations, and authorization letters for global submissions.
- Review technical documentation (BMRs, stability data, validation reports, CoAs, etc.)
- for compliance and manage regulatory responses to health authority and client queries.
- Coordinate artwork review for PILs, SmPCs, labels, and cartons per country-specific guidelines.
- Collaborate with QA, QC, and production teams for data collection and document archival.
- Oversee CoPP applications and support dossier preparation for new market registrations.
TECHNOLOGIES
CTD, ACTD, Country-Specific Dossiers, MS Office, Document Management Systems
Junior Executive – Regulatory Affairs
Claris Injectables Ltd.
November 2014 – May 2016
- Assisted in the compilation of CTD/ACTD dossiers and response documentation.
- Supported the preparation and maintenance of regulatory files for international submissions and ensured timely coordination with internal stakeholders for dossier completeness.
TECHNOLOGIES
CTD, ACTD, Regulatory Documentation Systems
Executive – Regulatory Affairs
Swiss Exports Pvt. Ltd.
August 2011 – October 2014
- Compiled registration dossiers for tablets, capsules, and injectables for ROW markets.
- Reviewed technical data, coordinated with internal teams for dossier completion, and ensured adherence to regional regulatory requirements.
TECHNOLOGIES
Regulatory Submissions (ROW Markets), Dossier Compilation Tools, MS Office
