Mona R. Zarifa, Ph.D.

Expertise

Over 15 years experience in the application and interpretation of standards and Standard Operating Procedures of FDA, EPA, United States Pharmacopoeia (USP), and AOAC.
Twelve years experience related to FDA’s regulations, policy, and evaluation of Chemistry, Manufacturing, and Control (CMC) data in pharmaceutical industry applications for prescription and over-the counter drugs, as well as applying and interpreting FDA’s policies, guidelines, and guidances relating to drug development and approval.
Twelve years experience in support of FDA's efforts to establish and disseminate guidance to the pharmaceutical industry in the area of CMC.
Contract work in support of EPA programs including review work for approval of premanufacturing notices (PMNs), pesticides registration applications, solid wastes listing/delisting petitions and analytical methods development (SW methods manual) .
Extensive involvement with the botanical scientific and regulatory community, including active participation in national workshops and conferences and giving presentations.
Team leader for CMC teams of 3-10 chemistry reviewers (FDA and EPA) for 4 years.
Academic research related to chromatographic separations and experience in a pharmaceutical quality control laboratory.

Professional Experience

Jan. 2003 - Present

Regulatory Chemist
Salamandra, LLC, Bethesda, MD

Responsible for responding quickly to client requests for guidance on filing strategies, applicable regulations, and the evaluation, selection, and organization of scientific information and data to be included in drug applications or dossiers.
Assists clients with reviewing and assessing CMC documentation related to Due Diligence processes. .
Regularly participate in planning meetings with clients and regulators to provide regulatory and scientific support, and communicate with regulatory agencies on behalf of clients.
Responsible for authoring CMC sections of new and generic drug applications (NDAs, ANDAs, CMC supplements, INDs, DMFs, and non-US regulatory submissions)

Sept. 2000-
Jan. 2003 &
Sept. 1993-
Dec. 1999

Senior CMC Reviewer , Neuropharmacology Drug Products Division
U.S. Food and Drug Administration, Rockville, MD

Responsible for CMC reviews for INDs, NDAs, DMFs and CMC supplements, writing comprehensive reports, and participating and providing chemistry input in regular Division meetings on approvability of INDs and NDAs.
Communicated with the industry in meetings, teleconferences, and in writing to resolve scientific and regulatory issues.
Communicated with other chemists and reviewers of other disciplines.
Coordinated with field offices, laboratories, and the office of compliance and actively participated in technical committees providing guidance on technical and regulatory issues pertaining to the CMC review process.

Jan. 2000 -
Sept. 2000

CMC Team Leader in support of the Divisions of Anti-Inflammatory & Analgesics and over-the-Counter Drug Products, FDA

Supervised a team of five review chemists and served as principal advisor to HFD-550 and HFD-560 Division Directors for CMC issues in the anti-inflammatory and analgesic as well as over-the-counter drug categories.
Successfully led team through transition period and brought them up to speed; established, maintained, and coordinated effective tracking systems for assignments and workload.
Participated in over 22 Pre-NDA/End-of-Phase II and over 15 pre-IND meetings with sponsors.
Provided mentoring to reviewers and maintained excellent communication on the team level as well as the management level, and monitored/documented work performance.

Jan. 1992 -
May 1993

Regulatory Program Manager/Senior Chemist
Science Applications International (SAIC), Falls Church, VA

Provided chemistry and regulatory support of contract work with the U.S. Environmental Protection Agency (EPA), including evaluation of chemical manufacturing processes, identification and verification of chemical components in manufacturing and waste processes in support of the Office of Solid Wastes.
Responsible for evaluation of chemistry, manufacturing, and controls of pesticide registration applications, new chemicals applications, and database management in support of these activities.
Served as principal reviewer of chemistry information in the NLM/NIH Hazardous Substances Data Bank (HSDB).
Participated in the drafting of over 15 notices of new rule making, their background documents, and responses to public comments.

Sept. 1987 -
Jan. 1992

Regulatory Program Manager
Dynamac Corporation, Rockville, MD

Provided chemistry and regulatory support of contract work with the EPA, including evaluation of chemical manufacturing processes, identification and verification of chemical components in manufacturing and waste processes in support of the Office of Solid Wastes.
Responsible for evaluation of chemistry, manufacturing, and controls of pesticide registration applications, new chemicals applications, and database management in support of these activities.

Sept. 1984 -
Aug. 1987

Chemistry Team Leader
InterAmerica Research Associates (in-house at EPA), Washington D.C.

Provided chemistry and regulatory support of contract work with the EPA, including evaluation of chemical manufacturing processes, identification and verification of chemical components in manufacturing and waste processes in support of the Office of Solid Wastes.
Responsible for evaluation of chemistry, manufacturing, and controls of pesticide registration applications, new chemicals applications, and database management in support of these activities.
Conducted secondary reviews, supervised technical performance of the group, group communication with industry, and coordination between the group, the contractor, and the EPA Division Chief and chemists.

Professional Activities

Education

Ph.D. Chemistry, The American University, Washington D.C. (1984)
M.S. Solid State Science, The American University, Cairo, Egypt (1979)

B.S. Chemistry, The American University, Cairo, Egypt (1975)

Honors, Awards, and Certifications

FDA On-The-Spot Award July & Nov. 1996
FDA Commendable Service Award 1997
FDA Group Award and Certificate of Appreciation 1999
CDER Special Recognition Award, FDA 2000
FDA Certificate of Appreciation in Training and Communication in CDER 2000, 2001
FDA Team Excellence Award for developing core competencies for chemists 2001
FDA Excellence in Mentoring Award 2001

Publications

International Experience and Foreign Languages