Manager Regulatory Affairs

Role Overview: You will be responsible for the CMC review of technical documentation for regulatory filings across various markets including the US. This will involve conducting Gap Analysis and Remediation for Module 3 - CMC. Additionally, you will play a key role in the development and implementation of regulatory strategies, processes, and timelines for the grant of Marketing Authorization in regions such as Africa, GCC, LATAM, and ASEAN. Key Responsibilities: - Reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. - Critically reviewing documentation intended for submission to regulatory agencies to ensure internal consistency and adherence to relevant guidelines, thereby promoting regulatory excellence. - Demonstrating expertise in the subject matter and relevant areas, collaborating effectively with internal and external clients, and facilitating clear and efficient communication for operational excellence. - Maintaining a high level of knowledge regarding country regulations and regulatory guidelines, as updated from time to time on various agencies" websites. Qualifications Required: - Hold a Master's degree in Pharma. - Possess relevant experience equivalent to 7 to 10 years. - Strong technical data interpretation skills, interpersonal skills, oral and written communication skills, and knowledge of US Regulations. - Proficiency in using computer applications such as Excel, Outlook, and document management systems. - Ability to work effectively in a team-oriented environment, under pressure, and within tight timelines. Additional Details: The position may require you to work in slots catering to different time zones as needed. The job is based in Gurgaon, Haryana, India. Join the global regulatory team as an Assistant Manager in Regulatory Affairs, focusing on the US market and beyond.,