REGULATORY EXECUTIVE @ SANGHARSH
We are seeking a Regulatory Executive to manage pharmaceutical product registrations and compliance for the Myanmar market. This role involves the preparation and submission of CTD and ACTD dossiers tailored to Myanmar's regulatory framework. The candidate will work as part of a fast-growing team, managing product lifecycles and ensuring that all regulatory queries from local authorities are addressed promptly. Coordination with cross-functional teams is vital for maintaining the efficiency of submissions.
The ideal candidate must have a minimum of 5 years of experience in Regulatory Affairs and hold an M.Pharm degree. Proficiency in documentation tools like Microsoft Office and Adobe PDF is essential, alongside familiarity with AI tools for task management and documentation. This position offers a chance to work in a dynamic environment dealing with diverse international markets including Myanmar, Cambodia, and other ROW regions. Preference will be given to candidates who can join immediately.
The ideal candidate must have a minimum of 5 years of experience in Regulatory Affairs and hold an M.Pharm degree. Proficiency in documentation tools like Microsoft Office and Adobe PDF is essential, alongside familiarity with AI tools for task management and documentation. This position offers a chance to work in a dynamic environment dealing with diverse international markets including Myanmar, Cambodia, and other ROW regions. Preference will be given to candidates who can join immediately.
Key Requirements
Minimum 5 Years of experience in Regulatory Affairs within the Pharmaceutical industry.
Educational qualification of Master of Pharmacy (M.Pharm) is required.
Strong expertise in the preparation, compilation, and submission of CTD/ACTD dossiers.
Proven experience in lifecycle management of products across multiple global markets.
Ability to handle and respond effectively to regulatory queries and deficiencies.
Excellent coordination skills with cross-functional teams to ensure timely submissions.
Comprehensive understanding of regulatory guidelines for ROW (Rest of World) markets.
Hands-on experience with Microsoft Office tools for professional documentation.
Proficiency in using Adobe PDF tools for dossier compilation and editing.
Familiarity with AI tools for documentation and modern task management platforms.