Deepesh B Varma

In this role, I have,

• Lead product registrations and life cycle management for Biologics and Biosimilars in Latin American region (Colombia, Chile, Peru, Mexico, Bolivia, Guatemala, Paraguay, Jamaica and Trinidad & Tobago).
• Kept abreast of changing regulatory landscape worldwide.
• Authored high quality CMC reports and dossier packages for biologics to ease Health Regulatory Agency submissions, facilitate application of CMC global regulatory strategies.
• Liaisoned with country regulatory partners/affiliates to ensure timely dossier submission, enable responses to MoH queries on time to expedite product registration in countries and setting regulatory strategies for change implementation.
• Compiled of country specific dossiers for product registrations as per country regulatory checklist.
• Acted as regulatory connect in multi-function team to enable development of regulatory CMC strategies for pipeline product
• Reviewed primary documents with respect to CMC/NC and responsible for closure of regulatory/ partner queries with respect to CMC data.
• Administered Institutional Biosafety Committee and filings (Import/export permits, annual reports, preclinical toxicity study filings) to RCGM.
• Supported process applications and procurement of regulatory licenses/certificates.
• Prepared and submitted regulatory applications and supporting documentation to Health authorities to enable product registrations and life cycle management of approved products

In this role, I established an independent team for cell banking operations and managed a team of 10 people in upstream biosimilar manufacturing (Cell banking and cell culture operations). My responsibilities included,

• Resource management and ensuring adherence to production plan.
• Maximized performance by monitoring daily activities and mentoring team members.
• Delivered feedback to decision-makers regarding employee performance and training needs.
• Authoring and review of quality and technical documents like MFR, BPR, SOPs, protocols, technical reports.
• Managing QMS elements including QRMs, incident investigations and change control procedure and adherence to GMP compliance.
• Managing equipment Lifecycle, CAPEX proposals, budgeting.
• Supporting addressing of regulatory queries and inspections (INVIMA, ANVISA, WHO, MoH-Ukraine, Russia, Peru, Turkey, Indonesia and various partner audit.
• Safety zone owner responsible for implementation of continuous monitoring systems and controls to ensure safety of personnel working in respective zone.