Senior Manager -Regulatory & Business Continuity USFDA (CMC

About the role

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

What you'll do

• Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling…
• Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions
• Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy
• Review & prepare response to deficiency enabling approval of products filed to regulatory agency
• Prepare and review variation, Annual notification and labelling approval for US and OAM

What you need

• Regulatory affairs
• Compliance
• Chemistry
• M.Pharm