Andy Papas
- Role
- Vice President of Regulatory Affairs at Nsf - Life Sciences
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Andy Papas
Pharmaceutical/Biotech industry executive with proven success in developing and…
Experience
Vice President of Regulatory Affairs
Jul 2013 — Present · 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
Education
Boston University
BA, Chemistry
University of Massachusetts Lowell
PhD, Chemistry
Boston University - School of Management
MBA, International Business & Team Dynamics
2000 — 2001
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