Manager Regulatory Affairs

As a Regulatory Affairs professional in our company, you will play a crucial role in ensuring compliance with regulatory guidelines and maintaining the highest quality standards in the technical documentation for regulatory filings. Your responsibilities will include: - Conducting CMC review of technical documentation for regulatory filings to various markets, with a focus on the US market - Performing Gap Analysis and Remediation for module 3 -CMC - Developing and implementing regulatory strategies, processes, and timelines for grant of MA in regions like Africas, GCC, LATAM, ASEAN - Reviewing CTD dossiers, variations, change controls, renewals to ensure compliance with regulatory guidelines - Ensuring internal consistency, adherence to relevant guidelines, and promoting regulatory excellence in documentation for submission - Demonstrating expertise in subject matter and regulatory knowledge - Collaborating with internal and external clients for effective communication and operational excellence To excel in this role, you should possess: - A Master's degree in Pharma - 7 to 10 years of relevant experience or equivalent combination of education and training - Excellent technical data interpretation and interpersonal skills - Strong oral and written communication skills with proficiency in presentations - Significant knowledge of US Regulations - Proficiency in document management systems, Microsoft Word, PowerPoint, Excel - Ability to work in a team-oriented environment and deliver quality outputs within tight timelines Additionally, you should be flexible, adaptive, and capable of working under pressure. As part of the job requirements, you may need to accommodate working slots catering to different time zones. Join us in Gurgaon, Haryana (INDIA) and be a part of our team dedicated to regulatory affairs in the pharmaceutical industry.,