Isabel has been with NDA since 2013, a Regulatory affairs expert with over 30 years of experience, covering European and US regulatory procedures, requirements and strategies, clinical development, and preparation of EU and US agency meetings, for several therapeutic areas including oncology, rare diseases, neurology, and pain. She has successfully supported numerous clients ranging from large Pharma to small biotech companies in the EU and US.
Key Areas Of Expertise
- Extensive knowledge of EU and US regulatory requirements and procedures (MAA, NDA/BLA, Scientific Advice, PIP/PSP, ODD, CTA, IND).
- Broad regulatory affairs experience in supporting early to late-stage clinical development with focus on oncology drugs including immuno-oncology therapeutics.
- Successful co-ordination of and strategy generation for clinical documents of major regulatory submissions and regulatory roadmaps.
- Proven leadership skills in navigating global project teams through agency interactions and scientific advice/milestone meetings (EMA, FDA and national agencies) including preparation of the respective briefing packages.
- MAA/NDA and CTA/IND preparation including agency interactions, project management, writing or review of clinical eCTD modules and responses to agency questions, as well as maintenance activities.
- Strategic advice on and writing of PIP/PSP and ODD applications and support of the respective agency interactions during the procedure including response preparation to agency questions and co-ordination of related agency meetings.
Isabel joined the pharmaceutical industry in 1989 in pharmacology research and worked in regulatory affairs since 2001 in large Pharma. Most recently as Associate Director with global regulatory lead functions in the US (6 years).
Biologist, PhD in Natural Sciences, Master of Drug Regulatory Affairs (MDRA)
Dr Isabel Schemainda