Specialist Global Regulatory Affairs
Current• Provided Guidance and regulatory expertise to other departments in support to product development and product life-cycle management in regards to different Agencies like FDA, Health Canada and other.• Supported regulatory redaction of briefing package (Pre-IND Meeting), preparation of meeting minutes and responses to agencies questions pre and post drug products approval.• Provided regulatory assessments for change management and ensures compliance of the regulatory submissions by filing and/or coordinating regulatory amendments in relation to the change.• Prepared submission like Comparability protocol, Stability protocol, Changes to NDA in regard to up-scaling while working on module 1,2 and 3, Annual Report for Health Canada and FDA. • Supported in preparation of Product Indication Expansion.
