Hima Sankar

Senior Regulatory Cmc Manager @SUBSTIPHARM

London, GB

As a Senior CMC Regulatory Affairs Manager, I\'m all about making sure our pharmaceutical submissions are spot on. I lead the drafting, reviewing, and finalisation of Module 3 documents, which is a big chunk of what I do. It\'s all about bringing together intricate scientific and technical data into detailed documentation for successful submissions of new dossiers.You\'ll often find me spearheading the organisational design and delivery of premier New Marketing authorisations and post-approval amendments. I\'m the go-to person when it comes to representing our corporation in initial consultations with key agencies like EMA and MHRA, building profitable partnerships, and ensuring a smooth documentation submission process.One of my strengths is in innovating regulatory project management. I love getting strategic with documentation creation and submission planning to ensure everything is up to scratch. Plus, I\'m the chief CMC liaison with our development and manufacturing sites, making sure all our products comply with regulations and maintain regulatory integrity.When it comes to technical documents, I\'m your guy for evaluating specifications, batch manufacturing data, pharmaceutical development summaries, and more. I make sure everything aligns perfectly with the rules and regulations.Here are some highlights of my journey at Substipharm:• Orchestrated drafting of CMC sections for global marketing permissions.• Provided supervision for post-approval activities.• Led a top-performing team in the submission of new dossiers and post-approval changes.• Crafted robust replies to queries from regulatory bodies.• Secured regulatory conformity and mitigated hazards through expertise.• Obtained licenses by overseeing regulatory file assessments.• Imparted regulatory wisdom for commercial contracts and agreements.• Enabled evaluation of manufacturing changes and ensured regulatory adherence.

Andhra University

Ph.D