Marva have served as the primary liais on for diverse products across therapeutic areas from the pre-IND stage through NDA/BLA submission and registration. She has actively contributed both as a scientist and as a strategic regulatory liaison to several NDA/BLA and MAA approvals. In addition, she has contributed to INDs, NDAs, BLAs, DMFs and CTAs across diverse therapeutic areas. Specialties: Vaccines and Drug Regulatory Strategy, Leadership, Preclinical and Clinical Development, Clinical Trial Project Management, Quality Management, Contract Negotiation, CRO/CMO management, Grant Writing, Clinical and Translational Research, Collaborations, Regulatory Research, Health Authority Interactions

Associate Director, Regulatory Affairs @ From August 2014 to Present (1 year 5 months) cambridge, massachusettsSenior Manager Regulatory Affairs, North America @ From September 2013 to July 2014 (11 months) cambridge, maDirector - Regulatory Affairs and Quality Assurance @ Direct management of all vaccine programs Direct management of Quality Systems Plans, prepares, and manages timelines for all regulatory documentation and regulatory responses for submissions including initial Investigational New Drug applications (INDs), IND amendments, Clinical Trial Applications (CTAs), New Drug Applications (NDAs), orphan drug designations, meeting requests, Manufacturing & Controls (CMC), preclinical and clinical submissions as well as programs to assure that all development activities are in compliance with applicable regulations and guidelines. Represent Regulatory Affairs at various project strategy team and working group meetings; Assess and communicate regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines; Develop regulatory strategy plans; Liaise with partnering companies to ensure regulatory alliance; Act as direct point of contact with FDA and other regulatory authorities. Manage and Mentor junior regulatory/quality staff and other team members. From July 2011 to August 2013 (2 years 2 months) Washington D.C. Metro AreaAssociate Director, Regulatory Affairs and Quality - Vaccine Development @ From June 2010 to August 2011 (1 year 3 months) Washington D.C. Metro AreaRegulatory Affairs Manager @ From August 2007 to June 2010 (2 years 11 months) Senior Scientist @ Formulation Development and Analytical Chemistry From 2005 to 2007 (2 years) Senior Staff Scientist @ Pharmacokinetic studies for projects at the drug discovery stage, IND-enabling studies, as well as toxicokinetic and clinical pharmacokinetic studies. PK/TK analysis for a preclinical or clinical study using validated software programs such as WinNonLin and Watson and LC/MS/MS for quantitation. From 2004 to 2005 (1 year)

Executive Development Program @ Northwestern University - Kellogg School of Management From 2013 to 2013 Certificate, Clinical Trial Project Management @ Montgomery College From 2012 to 2012 M.S., Bioscience, Regulatory Affairs @ The Johns Hopkins University From 2007 to 2009 MBA, Business Administration/Leadership @ Wesley College From 2006 to 2008 Bachelor of Science (BS), Chemistry @ Delaware State University From 1990 to 1993 Marva Schödel is skilled in: Regulatory Affairs, GMP, Quality Assurance, Clinical Development, Vaccines, Analytical Chemistry, FDA, Biotechnology, Validation, cGMP, Quality Systems, Pharmaceuticals, GLP, GCP, Regulatory Submissions