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5.0 - 8.0 years
3 - 6 Lacs
Hyderabad
Work from Office
Role & responsibilities Review and authorize change controls, assessing their impact on regulatory submissions. * Coordinate and organize meetings with cross-functional teams to discuss IRs, DRLs, and CR letters from agencies; circulate Minutes of Meeting (MoM) and follow up on action items. * Compile and coordinate high-quality CMC regulatory submissions for the US market in compliance with current regulatory guidelines and timelines. * Assess change controls from formulation plants and categorize them based on risk to product quality and compliance. * Plan, review, and submit CBE, CBE-30, and Prior Approval Supplements (PAS). * Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines. * Evaluate and interpret post-approval changes including: * Alternate excipients * Alternate packing materials * Alternate API source additions * Site and pack additions * Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages. * Assist in developing standards and SOPs for operations and production procedures. * Stay updated with evolving global and regional regulations affecting submissions. * Provide daily activity updates to the Regulatory Affairs Manager. * Prepare monthly reports and provide timely updates to superiors. * Uphold the highest standards of professional integrity in all RA activities. * Actively participate in continuous improvement initiatives within the department. Preferred candidate profile * Master's degree in Pharmaceutics, Pharmaceutical Analysis, Regulatory Affairs. * Strong knowledge of US FDA regulatory guidelines and CMC documentation. * Excellent communication, coordination, and documentation skills. * Attention to detail and ability to manage multiple priorities effectively.
Posted 1 week ago
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