Senior Executive

Role Overview: As a Senior Executive at Dishman Carbogen Amcis Limited in Bavla, Gujarat, you will be responsible for preparing DMF / ASMF / CEP dossiers following ICH M4 CTD/eCTD guidelines. You will also handle responses to queries from regulatory agencies and customers, prepare Applicants Part of ASMF based on customer requirements, and manage renewals and revisions for CEPs / annual reports for USDMFs / ASMF variations. Additionally, you will stay updated on global regulatory requirements, evaluate change control applications for regulatory implications, and provide regulatory input for analytical method validation reports and stability protocols. Key Responsibilities: - Prepare DMF / ASMF / CEP dossiers in compliance with ICH M4 CTD/eCTD guidelines - Respond to queries from regulatory agencies and customers - Create Applicants Part of ASMF as per customer needs and restricted part of ASMF as per regulatory requirements - Initiate timely notification / prior approval from regulatory agencies for any changes to existing DMF / ASMF / CEP - Manage renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations - Stay updated on current global regulatory requirements - Evaluate change control applications for regulatory implications - Review analytical method validation reports, stability protocols, and standard operating procedures, providing regulatory input as needed Qualifications Required: - Bachelor's degree in a relevant field such as Law or Legal - Knowledge of ICH guidelines and regulatory requirements - Strong attention to detail and ability to work with regulatory documents - Excellent communication skills to interact with regulatory agencies and customers,