Amy M. Byrom
Centerport,USA
Summary
Over 30 years of U.S. and international pharmaceutical experience in regulatory affairs and project management for NCE and generic drug products. Interact with FDA and international regulatory agencies to facilitate new product development and secure product approvals. Develop and execute regulatory strategies and partner cross-functionally to maintain timelines and achieve corporate objectives.
Overview
31
31
years of professional experience
Work History
PHARMACY TECHNICIAN
Lancaster, PA
DIRECTOR, REGULATORY AFFAIRS (REMOTE)
SANDOZ INC.
Princeton, NJ
01.2020 - 01.2026
- US Regulatory Strategy Head for oral solid and semisolid portfolio pipeline. Recommend the most effective path to regulatory approval to bring the company’s products to market in a cost-effective, compliant manner. Advise on development issues, anticipate regulatory risks and define mitigation strategies. Supervise staff in preparation and submission of INDs and ANDAs. Prepare meeting packages and act as firm’s lead representative in FDA meetings. Negotiate alternative bioequivalence approaches with FDA. Manage complex manufacturing site transfer of entire semisolid product portfolio to ex-US sites. Evaluate new portfolio projects and conduct due diligence for business development and in-licensing opportunities.
DIRECTOR, REGULATORY AFFAIRS
FOUGERA PHARMACEUTICALS INC., A SANDOZ COMPANY
Melville, NY
01.2013 - 01.2020
- Regulatory Head for the dermatology franchise and member of Site Leadership Team. Developed regulatory strategies for products from development through life-cycle management. Primary point of contact with FDA. Recommended nonclinical and clinical programs for development pipeline. Managed regulatory staff in the preparation of all modules of IND/NDA/ANDA submissions, including CMC (Module 3) and Clinical Bioequivalence (Module 5). Evaluated new product development opportunities and conducted due diligence for potential acquisitions/in-licensing opportunities. Taught generic drug approvals course for the Center for Professional Advancement.
ASSOCIATE DIRECTOR, REGULATORY AFFAIRS – FDA LIAISON/STRATEGY/ SUBMISSIONS
FOUGERA PHARMACEUTICALS INC, MELVILLE, NY (FORMERLY NYCOMED US INC)
Melville, NY
01.2005 - 01.2013
- Developed and executed regulatory strategies and acted as primary contact with FDA. Recommended nonclinical and clinical development programs for development pipeline. Managed regulatory staff in the preparation of all modules of IND/NDA/ANDA submissions, including CMC (Module 3). Acted as lead representative in meetings with FDA. Evaluated new product development opportunities and conducted due diligence for potential acquisitions/in-licensing opportunities. Assisted in internal preparation for Paragraph IV litigation (gave depositions, produced discovery documentation). Provided regulatory guidance on Investigator Initiated Trials. Reviewed/approved advertising and promotional materials. Secured DEA registration.
- Obtained first industry-wide preservation of 180-day generic exclusivity despite >30-month review
- Managed implementation of fully electronic submissions in less than one year
- Promoted from Manager
MANAGER, SCIENTIFIC PROJECTS & PROJECT MANAGEMENT
01.2002 - 01.2005
- Established and managed the project management function in the Scientific Affairs department (Product Development, Analytical Research and Development, Clinical Operations, Regulatory Affairs, Quality Assurance, Project Management). Managed project timelines. Analyzed FDA review times and implemented action plan to reduce approval times. Negotiated patent listing and pediatric exclusivity for new products. Prepared company responses to FDA Citizen Petition. Evaluated new product development opportunities.
SENIOR REGULATORY ASSOCIATE
01.1998 - 01.2002
- Managed the US development and regulatory filings for NCEs including oral solid, inhalation and topical dosage forms. Developed and executed regulatory strategies and acted as primary liaison between company and FDA. Prepared and filed original INDs/NDA and IND/NDA/ANDA amendments, annual reports and safety reports. Attended and documented FDA meetings and teleconferences (pre-IND, EOP2, Advisory Committee, etc.). Reviewed documentation and provided regulatory approval for shipment of clinical trial supplies. Reviewed and approved informed consent templates for all clinical studies for assigned projects. Supervised Regulatory Submissions Coordinator.
- Secured orphan drug designation
- Coordinated submission of emergency use IND for critically ill pediatric patient
- Promoted from Regulatory Assistant and Regulatory Associate
REGULATORY ASSOCIATE
WYETH-AYERST RESEARCH
St. Davids, PA
01.1995 - 01.1998
- Compiled dossiers, data packages and supportive materials for new regulatory submission in Middle East markets. Maintained marketing privileges for existing product registrations. Determined sourcing options for new products. Advised project teams on feasibility of projects in assigned areas. Assisted department vice-president on management of strategic international regulatory committee. Trained new associates.
Education
B.A. - Spanish/Business minor
Immaculata University
PAundefined
University of Madrid
SpainContracts, Civil Procedure, Torts
Hofstra University School of Law
Financial Accounting, Business Statistics, Economics, Management Information Systems, Business Calculus
Villanova University MBA Program
Skills
- MS Word, MS Excel, MS PowerPoint, MS Teams, MS Project, MS Outlook, MS OneNote, Adobe Acrobat Pro, 1QEM, Trackwise, Visio, DocuBridge, Documentum, LIMS, SAP
Affiliations
Regulatory Affairs Professionals Society (RAPS) (Contributing author to the first edition of Fundamentals of Regulatory Affairs)
Timeline
DIRECTOR, REGULATORY AFFAIRS (REMOTE)
SANDOZ INC.
01.2020 - 01.2026
DIRECTOR, REGULATORY AFFAIRS
FOUGERA PHARMACEUTICALS INC., A SANDOZ COMPANY
01.2013 - 01.2020
ASSOCIATE DIRECTOR, REGULATORY AFFAIRS – FDA LIAISON/STRATEGY/ SUBMISSIONS
FOUGERA PHARMACEUTICALS INC, MELVILLE, NY (FORMERLY NYCOMED US INC)
01.2005 - 01.2013
MANAGER, SCIENTIFIC PROJECTS & PROJECT MANAGEMENT
01.2002 - 01.2005
SENIOR REGULATORY ASSOCIATE
01.1998 - 01.2002
REGULATORY ASSOCIATE
WYETH-AYERST RESEARCH
01.1995 - 01.1998
Financial Accounting, Business Statistics, Economics, Management Information Systems, Business Calculus
Villanova University MBA Program
Contracts, Civil Procedure, Torts
Hofstra University School of Law
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University of Madrid
PHARMACY TECHNICIAN
B.A. - Spanish/Business minor
Immaculata University