- Extensive experience in the pharmaceutical and biotechnology industry with a background in biological product development
- Experienced in all aspects of regulatory affairs for both biologics and small molecules
- Proven track record in delivering regulatory strategies and submissions for products in development and marketed products
- Co-ordinated and managed projects ranging from scientific advice/protocol assistance, ODD, PIPs, CTAs, pre-submission meetings, MAAs and lifecycle management for EU centrally approved products.
- Managed interactions and negotiations with regulatory authorities within the EU