Senior Pharmaceutical Regulatory - Regulatory Strategist Consultant: FDA, CDER, CBER, CVM, and Compliance

Technical Consultant #2366


Expertise

  • Expediting pharmaceutical services in: Pharmaceutical regulatory, Quality Assurance (QA), global pharmaceutical support, investigational and drug development.
  • Enhancement and development of regulatory affairs with an overall development of regulatory strategy for business models through evaluation and control of pipeline products for commercial and drug development venture companies.
  • Building pharmaceutical regulatory departments and assessing their effectiveness in parallel with Company objectives.
  • Preparation of chemistry, manufacturing and control sections of global regulatory Dossiers (IND, NDA, BLA and MAA), post-approval supplements (NDA and BLA) and variations (MM).
  • Preparation of regulatory documentation for the U.S. (e.g., INDs, (A)NDAs, DMFs, NADAs and CTDs) and International Regulatory authorities (e.g., CTAs, IMPDs and CTDs.
  • GXP auditing - for paper reviews to onsite audits.
  • Pharmaceutical strategic planning and filing regulatory specific to pain management within FDA division.
  • Regulatory: Utilizing genomics and micro-dosing; targeting the Oncology Division at FDA in tandem with FDA's science division.
  • ICH guidelines and FDA guidance documents as well as EMEA guidance, relevant to global pharmaceuticals
  • CMC sections supporting NADAs and GRAS ingredients.
  • FDA - CDER Primary Chemistry Reviewer.
  • Review and regulatory operational preparation of original INDs, NDAs, BLAs, NADAs, ANDAs, amendments, annual reports, supplements, safety reports, DMFs through paper and eCTD formats processed by mail or through the electronic portal.
  • FDA regulatory and CMC interactions for approval of abbreviated products.
  • FDA liaison on the regulatory and CMC interactions for approvals of products in medical imaging products, endocrine and metabolism, pulmonary, blood products and pain management.
  • Processing biosimilar like products such as fatty acids, glycosides, glycosamines and other small molecule and more complex drug substances supportive of drug master files, INDs and NDAs and (A)NDAs.
  • Regulatory operations.
  • Preparation of eCTDs for transmission to FDA.

Experience

Undisclosed Company, Proprietor, 2004 - Present

  • A Regulatory Strategist for clients primarily in the pharmaceutical, medical device, biologic, and biotechnology industries, assisting in drug development supported by quality assurance in compliance with FDA regulations.
  • Strategic project planning and regulatory strategy development in CDER (new drugs and generics), CBER, and CDRH.
  • Strategic project planning and regulatory strategy development in CVM (new drugs, generics and GRAS ingredients).
  • Works collaboratively with FDA on critical path initiatives that have specifically addressed genomics (effective biomarkers) and micro dosing.
  • Due Diligence. Regulatory Intelligence, Gap Analysis.
  • CMC writing for FDA submissions (i.e., INDs, (A)NDAs, BLAs, DMFs).
  • Publishing of FDA submissions - eCTD and paper.
  • FDA liaison activities.
  • Quality review.

Gene Logic Inc., Gaithersburg, MD, Vice President, Regulatory Affairs, 2004 - 2005

  • Servicing clients in the pharmaceutical, medical, biologic, and biotechnology industries to create strategic plans for drug development supported by quality assurance in compliance with FDA regulations.
  • Strategic project planning and regulatory strategy development in CDER, CBER, and CDRH; heavy focus on oncology products.
  • Regulatory strategist bridging genomics and regulatory filings using the VGDS.
  • FDA submissions planning and development; FDA liaison activities.
  • Conducting assessments of client studies, procedures, and programs to determine compliance.
  • Developing and implementing corrective action plans to address deficiencies.
  • Regulatory compliance systems implement in Gene Logic Labs, Genomics and Drug Repositioning Systems.

AAIPHARMA® INC., Wilmington, NC, VP, 2003 - 2004

Vice President of Regulatory Affairs, Quality Assurance and Compliance

  • Created key drug development strategies for pain management products and opportunities aaiPharma® pipeline opportunities.
  • Successfully managed activities relating to all regulatory submissions.
  • Interacted with Business Development leading to the acquisition of Schedule II and III control substances for aaiPhama® Branded Products.
  • Established collaborative and active relationships with FDA in several Divisions: One NDA scheduled for filing; Three NDA supplements (CMC) approved; Labeling negotiations in progress for an injectable Schedule II drug; and Three successful PAIs completed in our oral and parenteral manufacturing facilities.
  • Completed Best in Class assessments for the Quality Programs.
  • Functionally aligned the Quality and Regulatory Organizations.
  • Successfully managed a department of 40 (10 RA; 30 QA) with recent increasing responsibilities to manage multiple departments in Quality and Compliance and Clinical Regulatory Compliance.

Elan Pharmaceuticals, San Diego, CA, Director, U.S. Regulatory Affairs, 2001 - 2003

  • Established interactive and collaborative relationships with Elan Senior Executives and with several key FDA officials.
  • Actively managed 8 drugs from initial drug development to post approval in pain management for the US market.
  • Key contributor to 10 due diligence projects of which five were actioned as strategic buys or sells for Elan.
  • Responsible for implementing key regulatory strategies throughout the company.
  • First accomplishment: approval of FROVA® a migraine drug.
  • Second accomplishment: approval of an opioid pain drug.
  • Initiated highly visible new drug development project for Elan with aggressive timeline actions for approval.
  • Implemented multiple number of programs for regulatory group.
  • Key contributor to several project teams.
  • Managed two associate directors and several consultants.

Alliance Pharmaceutical Corps, San Diego, CA, Senior Director, 1999 - 2001

Senior Director, Regulatory Affairs, Worldwide

  • Responsible for implementing regulatory strategies for drug development and regulatory submission for earliest possible approvals for Phase I through marketing approval and Phase IV in US, Canada, and Europe. Managed a team of 7.
  • Major accomplishment: Approval of Imavist, (now Imagent).
  • Participated in senior management development strategy teams for registration of products worldwide.
  • Responsible for improving the quality of all regulatory paper and electronic documents that has led to Alliance's first NDA into CDER.
  • Responsible for the identification of key regulatory requirements, communicating and influencing in a matrix project team environment with in-house and international project teams for four drug candidates and two device candidates and with corporate partners.
  • Responsible for ensuring timely review and preparation of all regulatory submissions, negotiating with regulatory agencies and facilitating regulatory agency review of submissions.

Amylin Pharmaceuticals, Inc., San Diego, CA, Senior Director, Regulatory Affairs, 1997 - 1999

  • Responsible for recommending and implementing regulatory strategies for drug development; filing regulatory submission for earliest possible approvals for Phase I through marketing approval and Phase IV in U.S. and Canada. Indirectly involved in European submissions.
  • Responsible for the identification of key regulatory requirements, communicating and influencing in a matrix project team environment with contract manufacturers, contract vendors, and corporate partners.
  • Responsible for ensuring timely preparation of organized, accurate, and scientifically valid submissions, negotiating with regulatory agencies and facilitating regulatory agency review of submissions.

U.S. Food and Drug Administration, Rockville, MD, Reviewer, 1991 - 1997

CMC Reviewer in Medical Imaging Division

  • Served on multi-disciplinary scientific and medical teams (Division of Medical Imaging and Radiopharmaceutical Products, Division of Dermatology and Dental Drug Products, Division of Ophthalmic Drug Products).
  • Served in overtime capacity to handle overflow of work assignments for Center that reviews, evaluates, and decides on the approvability of scientific submissions and applications that request FDA approval for clinical research; human testing, and human drugs.

Cambridge Isotope Laboratories, Woburn, MA, Production Director, 1988 - 1991

  • Supervised a relatively large group (6 PhDs and 15 BS) of scientists in the manufacture of stable isotopes for use in Investigational New Drug Applications and for industrial, governmental and academic use.

Bristol Meyers Squibb, Princeton, NJ, Senior Research Investigator, 1981 - 1988

  • Responsible for the design, development and execution of isotopically labeled compounds, their characterization and their preliminary analysis for clinical and non-clinical studies.

State University of New York, Buffalo, NY, Post-Doctoral Fellowship, 1979 - 1981

  • Responsible for the synthetic method development and publishing of sulfur based compounds.

Honors & Publications

Credentials

Expert Reviewer

  • Fosamax adverse events due to CMC Manufacturing issues - review and assess in report.
  • Oxycodone anti abuse failures - assessment.
  • GMP drug storage and potential failures leading to documented adverse effects for approved drugs.

Accredited Skills

  • Interdisciplinary Phamacogenomic Review Group
  • Pharmaceuticals manufacturing
  • CDER and CBER with ties to CDRH and CVM
  • Centralized and Mutual Recognition Regulatory Pathways in Europe
  • Drug development and review processes
  • CMC regulatory submission requirements
  • U.S. regulatory submissions
  • Operational system for performance record for paper and electronic submissions
  • Auditing performance record per GXPs

Education

  • Ph.D. Organic Chemistry, University of Pittsburgh, Pittsburgh, PA
  • B.S. Chemistry, Loyola College, Baltimore, MD
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