Assistant General Manager - DQA & RA

As an API Regulatory Affairs Manager, your role involves ensuring that API regulatory activities are carried out according to the specified time schedule and ensuring timely readiness of API regulatory documents/DMFs for new submissions/updates. You will be required to provide necessary regulatory support, advice, and guidance to the concerned API manufacturing sites and R&T Unit. Additionally, you will need to assure the quality of DMF submissions and maintenance, taking into consideration the company's Intermediates business. Your responsibilities also include providing technical inputs to Section Heads for APIs and Key for regulatory adequacy. Key Responsibilities: - Co-ordinate and collaborate with QA/QC/Production/Development departments of API/CDMO/Crop Business - Ensure adequate deficiency responses within stipulated timelines - Maintain compliance with KPIs of the global regulatory department - Implement, strengthen, and maintain the Quality Management System in accordance with ISO & Regulatory/cGMP guidelines (ICH Q7) at R&T Pune - Approve GMP documents such as batch records, Certificate of Analysis, Quality Technical Agreements, Site Quality Manual, Standard Operating Procedures, Site Master file, Validation master plan, and QMS documents at R&T Pune Site - Provide support to the development team (R&T) in process and analytical aspects for smooth functioning of scale-up activities and technology transfer to meet business expectations Qualifications Required: - Bachelor's degree in a relevant field (e.g., Pharmacy, Chemistry, Regulatory Affairs) - Strong understanding of API regulatory requirements and guidelines - Experience in regulatory affairs within the pharmaceutical industry - Knowledge of ISO & Regulatory/cGMP guidelines (ICH Q7) - Excellent communication and collaboration skills - Ability to work effectively in a cross-functional team environment This position offers the opportunity to be a key player in ensuring regulatory compliance and quality management within the API sector of the company.,