REGULATORY EXECUTIVE @ SANGHARSH
Sangharsh is seeking a dedicated and experienced Regulatory Executive to join our expanding pharmaceutical team in Ahmedabad. This role is pivotal for an individual with a minimum of 5 years of experience in Regulatory Affairs, specifically within the pharmaceutical sector. The successful candidate will be responsible for the preparation, compilation, and submission of CTD and ACTD dossiers, ensuring that all documentation meets the rigorous standards required for international markets. You will also manage the lifecycle of products across various global markets, including ROW regions like Nigeria, Myanmar, Kenya, Uganda, Tanzania, Ethiopia, Cambodia, Sudan, and regions across CIS and LATAM. Coordination closely with cross-functional teams is essential to ensure all regulatory submissions are made on time.
Beyond dossier preparation, the Regulatory Executive will handle and respond to regulatory queries and deficiencies, maintaining high standards of documentation and communication throughout the process. We are looking for candidates with a strong understanding of regulatory guidelines for international markets and hands-on experience with Microsoft Office, Adobe PDF tools, and modern AI tools for documentation and task management. If you are an M.Pharm graduate ready to take on a challenging and rewarding role in a fast-growing pharmaceutical organization, we encourage you to apply. Candidates who are immediate joiners and can start within one month are highly preferred for this position.
Beyond dossier preparation, the Regulatory Executive will handle and respond to regulatory queries and deficiencies, maintaining high standards of documentation and communication throughout the process. We are looking for candidates with a strong understanding of regulatory guidelines for international markets and hands-on experience with Microsoft Office, Adobe PDF tools, and modern AI tools for documentation and task management. If you are an M.Pharm graduate ready to take on a challenging and rewarding role in a fast-growing pharmaceutical organization, we encourage you to apply. Candidates who are immediate joiners and can start within one month are highly preferred for this position.
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.