Principal Consultant

Jill Challis

Jill joined NDA in 2006, with over 25 years’ experience gained within the European pharmaceutical regulatory environment, her extensive experience in European Regulatory Affairs covers all phases of product development and many therapeutics areas. She has successfully supported numerous clients ranging from large Pharma to small biotech companies globally.

 Key Areas Of Expertise
  • Specialist expertise in providing strategic advice and project management for EU Paediatric Investigation Plan (PIP) and US Pediatric Study Plan (PSP) applications and waiver/deferral requests, having been Project Manager for over 60 PIPs and advised on >100 paediatric related projects. Of the 60 projects: 8 have been in oncology and 15 in rare diseases, but has had oversight of the majority of NDA paediatric projects since 2007.
  • Extensive experience in European Regulatory Affairs through all phases of product development and including major Centralised MAA filings and post-marketing support, covering a broad range of product types including small molecules, vaccines, biologicals and gene therapies.
  • Advising on strategic considerations and regulatory roadmaps for new products in development to achieve the most efficient route to market so as not to delay innovative products reaching patients at the earliest opportunity.
  • Project managing all key EU submission types including CTAs, Scientific Advice requests, PIPs, ODDs, and MAAs, using both standard and accelerated procedures, interacting, negotiating and building upon existing relationships with European Regulatory Agencies, including the EMA and National Agencies.
Before NDA

Jill worked in the pharmaceutical industry for Synthelabo and Sanofi Aventis in roles including Regulatory Manager and Senior Regulatory Affairs Advisor and has worked for a Regulatory Agency.

BSc (Hons) in Applied Biochemistry and Physiology

Jill Challis

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