Manager Regulatory Affairs EM DDReg Pharma Pvt. Ltd.

7.0 - 11.0 years

0 Lacs

haryana

On-site

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. Your tasks will include reviewing CTD dossiers, variations, change controls, renewals, and ensuring their alignment with applicable regulatory guidelines while maintaining the highest quality standards. It is essential to critically review documentation intended for submission to regulatory agencies to ensure internal consistency and adherence to relevant guidelines, thereby promoting regulatory excellence. You will be expected to demonstrate expertise in the subject matter and relevant areas, collaborate effectively with internal and external clients, and facilitate clear and efficient communication for operational excellence. A high level of knowledge regarding country regulations and regulatory guidelines, as updated from time to time on various agencies" websites, is also required. To qualify for this position, you must hold a Master's degree in Pharma and 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 are essential requirements. Proficiency in using computer applications such as Excel, Outlook, and document management systems is necessary. Additionally, the ability to work effectively in a team-oriented environment, under pressure, and within tight timelines is crucial for this role. As part of the role, you may be required to work in slots catering to different time zones as needed. The position is based in Gurgaon, Haryana, India. Join us and contribute to our global regulatory team as an Assistant Manager in Regulatory Affairs, focusing on the US market and beyond.,

Posted 1 week ago

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