• 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

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