Andy Papas

Vice President of Regulatory Affairs @Nsf - Life Sciences

Washington, DC, US

Lead Pharma/ Biotech Regulatory Affairs with extensive experience providing strategic leadership and guidance on global regulatory affairs, quality, and drug development programs • Projects have included agency meetings (ex. PIND, EOP2, PNDA, type C, etc.), advising on regulatory strategy for early stage development through post approval changes, due diligence assessments for acquisition or investment, serving as the US Agent, advising OTC and generic companies, developing 505 (b)(2) NDA regulatory strategy and support from NDA submission leading to approvals, cGMP/GLP/GCP gap assessments and subsequent remediation, authoring/reviewing of submissions IND, BLA, NDA, ANDA, RFP, DMF contents, assisting with warning letters and import detentions, advising on strategy and global requirements of combination products, advising on biosimilar pathways, delivering eCTD compliant submissions, advising on clinical trials including recommendations of CROs and bioanalytical labs • Practice includes cadre of trusted experts with wide breadth of expertise available to clients on as-needed basis • CMC expertise spans US, EU, and CA biologics and combination product development, process and product control strategies, managing and authoring CTD Quality sections, method development, and lifecycle management changes • Work closely with Quality Systems group on many overlapping projects and have held leadership roles in FDA consent decree remediation efforts at several sites. o Focused on manufacturing and analytical laboratories, and have experience with GCP, GLP, and GPvP auditing reporting

Boston University

BA, Chemistry

University of Massachusetts Lowell

PhD, Chemistry

Boston University - School of Management

MBA, International Business & Team Dynamics