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.
Aug 2023 - Present
