Regulatory Affairs CMC (US Market) Life cycle management Aurobindo Pharma

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,...

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