Sonia Haley has over 30 years of experience in regulatory affairs and clinical research. She has worked with the FDA on numerous INDs, NDAs, and clinical trials across multiple therapeutic areas including cell therapies, biologics, and pharmaceutical drugs. Her experience includes developing regulatory strategies, compiling submissions, communicating with the FDA, and ensuring compliance. She is a licensed pharmacist and member of several professional organizations.

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SONIA M. HALEY
4012 Huntsteed Way
Richmond, Virginia 23233
Contact Information: 804.873.9315 or 804.364.3950; e-mail address: shvbsetter@comcast.net
SUMMARY STATEMENT: Regulatory affairs and clinical research professional with strong
interpersonal skills and expertise in the following areas:
Regulatory Affairs: IND development, NDA supplements and package inserts/labeling, FDA
communications and meetings/negotiations as well as Advisory Committee
preparation/presentation
Clinical Research: Review of clinical protocols, Investigator Brochures, safety reports and
study reports as well as research monitoring to assure compliance with GCPs, ICH
Guidelines and FDA regulations and guidances
EDUCATION: FairleighDickinson University, Teaneck, NJ, MA Chemistry, Business minor
Rutgers College of Pharmacy, Rutgers University, New Brunswick, NJ, BS
PROFESSIONAL EXPERIENCE:
REGULATORY AFFAIRS AND CLINICAL RESEARCH CONSULTANT
Cell-based Combination Biologic Device Product Development:
 Coordinated internal cross-functional team responses to FDA’s requests for information
following pre-IND meeting for a cell-based combination biologic device withFDA Center
of Biologics Drug Products (CBER); Summarized and internally disseminated exchange
of information asdiscussed with CBERconcerning sponsorcommitments to support IND
submission and subsequent development program
 Composed initial regulatory project management tracking document for individual IND
sectionsto support above forthcoming IND to be submitted to FDAinelectronic Common
Technical Document (e-CTD) format. Initiated electronic and backup paper IND
Regulatory File room based on pre-IND activities with FDA and ex-US clinical program
that would serve as the Phase 1 program for the US IND
 Assured communication flow between sponsor and outside vendors (e-CTD platform
and medical writers) for exchange of appropriate documents for integration into e-CTD
 Performed gap assessment of sponsor’s regulatory responsibilities for open regulatory
director position. Prioritized, coordinated, prepared and submitted all outstanding
documents to assure compliance with any US and non-US regulatory bodies
 Prepared and submitted IND Annual Reports to the FDA Office of Orphan Drugs for two
ophthalmologic orphan drug indications using cell-based therapy
 Communicated with Contract Research Organization (CRO) in Europe which
represented sponsor in the European Union (EU) to assure appropriate documentation
to support synchronization of orphan drug annual reports in the US and EU
 Prepared and submitted IND Protocol Amendments, Information Amendments and IND
Annual Report to FDA to support ongoing clinical trials for a cell-based combination

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biologic device for ophthalmologic indications; worked with cross-functional teams to
assure accuracy and completeness of FDA submissions
 Supported Clinical Department in building clinical Trial Master File (TMF) for initiated
investigational trials; performed sponsor quality assurance oversight of TMFs that were
conducted by CROs on three completed investigational studies
Pharmaceutical Drug Development:
 Reviewed Briefing Documents for sponsor’s FDA meetings and Advisory Committee
presentations; Assisted in coordination of potential FDA issues/concerns as well as
responses to FDA comments
 Reviewed individual IND and NDA sections, protocols and study reports, as well as
investigational brochures for accuracy, completeness and adherence to FDA and ICH
regulations/guidances prior to submission to regulatory bodies
 Compiled strategic packages for development of investigational compounds and for
prescription to over-the-counter use (Rx to OTC switches); wrote regulatory portions
 Compiled regulatory research packages for a corporate drug evaluation group in areas
including: endocrinology/metabolism, psychiatry/neurology and gastric disorders
 Summarized and evaluated FDA Drug Advisory Committee meeting transcripts, FDA
Review Summaries and European Union (EPAR) documents for impact on
investigational development programs and approved products
 Analyzed/proposed modifications to a Risk Evaluation and Mitigation Strategy (REMS)
program for newly approved New Drug Application(NDA) which were accepted by FDA
 Performed comparative labeling of currently approved drugs in various therapeutic
classes in anticipation of pending NDA drug approval to ascertain and anticipate
potential labeling issues that might arise during FDA labeling negotiations
 Researched clinical and regulatory requirements to support FDA designation of orphan
drug status for a variety of therapeutic indications
 Provided regulatory research/competitive intelligence and analysis for potential
pharmaceutical investors
CLINICAL RESEARCH COORDINATOR, Palmetto Health, Columbia, SC
 Coordinated a hemophilia research study sponsored by the Centers for Disease
Control concerning Creutzfeld-Jacobs Disease (CJD; also known as ‘mad cow’
disease); Invited to CDC as one of six study coordinators (from 150 U.S. centers) to
participate in focus group for having conducted study in exemplary manner
 Interacted as a team player with various hospital cross-functional teams and a fragile
patient population (immunocompromised hemophiliacs) to ensure high level of study
data while treating patients/families in a compassionate manner
 Drafted a quality assurance plan for Clinical Research department so that the
hospital could successfully pass an inspection by any regulatory branch
REGULATORY CONSULTANT/SENIOR ASSOCIATE, Johnson & Johnson, Raritan, NJ
 Served as regulatory project manager for anti-epileptic drug NDA, utilizing electronic
document management system for internal review and NDA publishing
 Managed IND program for a hormone replacement drug
 Coordinated company comments and responses to FDA Federal Register Notices
 Suggested a cross referencing system for an FDA submission which was accepted by
FDA and resulted in substantial savings of time and resources internally and to FDA
 Coordinated regulatory documents to allow for export of investigational epilepsy drug
 Presented regulatory strategy to Japanese partners for quinolone anti-infectives

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SENIOR CLINICALRESEARCHASSOCIATE,ClinTrialsResearch, Raleigh-Durham,
NC
 Served as Los Angeles, CA regional monitor and liaison between pharmaceutical
companies and the clinical investigators for Clinical Research Organization (CRO)
 Responsible for initiating and monitoring investigational studies in schizophrenia and
immunosuppression(liver transplants); ensured compliancewith Good ClinicalPractices
(GCPs), including reporting of adverse event data to Medical Monitors and sponsor
 Assisted manager in training of new regional clinical monitors
 Devised/implemented patient tracking system for a schizophrenia clinical trial
REGULATORY AFFAIRS MANAGER, Upsher Smith Laboratories, Minneapolis, MN
 Effectively addressed FDA'ssafety concerns which resulted in lifting an IND clinical hold
for a neurological drug with orphan drug designation
 Interacted with representatives from 4 FDA Divisions on a variety of issues concerning
development of new and generic drugs and continued marketing of approved drugs
(Cardiovascular/Renal; Neurology; Metabolism/Endocrine; Generic drugs)
 Coordinated activities and communications between sponsor, academic researchers
and FDA representatives from Division of Endocrine Drug Products and Office of
Generic Drugs to develop an in-vitro assay to serve as a bioequivalence protocol for a
non-systemically absorbed drug (see resulting FDA Draft Guidance on Cholestyramine)
 Successfully managed and trained regulatory and clinical staff
 Served as corporate Clinical Coordinator -- interfaced with investigators and CROs that
conducted clinical programs; Managed clinical trial budgets
 Presented clinical development plans and regulatory strategies to visiting Due Diligence
teams for potential joint marketing ventures
 Hosted inspections by FDA and Drug Enforcement Agency (DEA)
 Coordinatedand led presentations to two state formulary committeesresulting inproduct
being approved onto the formulary in both states
 Prepared a strategy and agenda for two End-of-Phase-2 meetings with FDA
 Reviewed all promotional, educational/training materials used by the Sales Department
REGULATORY AFFAIRS MANAGER and SENIOR REGULATORY SPECIALIST,
Hoffmann-La Roche, Nutley, NJ
 Assisted in coordinating, scheduling, reviewing, assembling and filing two NDAs
 Independently assembled and filed three original INDs for dermatologic products;
interacted with cross-functional teams to coordinate/compile required documentation
 Interacted with FDA representatives via oral and written communication; coordinated
meetings between Roche and FDA as necessary
 Participated in Due Diligence visit for company acquisition for regulatory issues
 Reviewed promotional materials and labeling for accuracy, completeness and
adherence to corporate and FDA standards
 Independently prepared and filed IND protocol amendments, information amendments
IND safety reports, annual progress reports and NDA supplements, annual reports and
periodic adverse drug experience reports
 Managed exchange of information with international Roche centers, including
Switzerland, Canada and Australia
 Invited by FDA reviewer to his retirement luncheon at the Officer’s Club in Washington
DC for exemplary work as sponsor liaison to FDA

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CLINICAL RESEARCH ASSOCIATE
 Coordinated studies to support a novel ‘screening IND’ program whose concept was
accepted by FDA; this resulted in a novel IND development prototype as well as an FDA
guidance entitled Exploratory IND Studies
 Acted as a first contact with clinical investigators reporting adverse drug experiences;
prepared safety reports for FDA submission
 Managed a compassionate use IND program (>100 investigational centers); Served as
point of conduct for investigators requesting participation in trial
 Monitored clinical studies in the field for safety, accuracy, completeness and compliance
with specified protocol (Good Clinical Practices, ICH and FDA guidances)
MASS SPECTROSCOPIST and ANALYTICAL CHEMIST
 Served as liaison between pilot plant, production and analytical laboratories
 Developed and performed assays utilizing wet methods and instrumentation
NUCLEAR PHARMACIST, Medi-Physics, Inc., Bloomfield, NJ
 Supervised nuclear pharmacy technicians in preparation of diagnostic radioisotopes
 Assured correct dispensing of radioisotopes to hospital nuclear medicine departments
PROFESSIONAL AFFILIATIONS:
Consulting Groups: Dohmen Life Sciences Services (DLSS), Denver; Guidepoint
Global Advisors, New York and YourEncore, Princeton
Association of Clinical Research Professionals (ACRP): Planning Committee member
for coordinating the 2012 and 2013 Central Virginia Chapter Fall Educational Symposiums
(including sponsorships, topics, speakers and facility)
2012 Speaker presentations: Analysis/implementation of FDA Guidance on Risk- Based
Monitoring; The Sunshine Act Update; Risk Management for Clinical Trials;
Effective/Efficient/Ethical Recruiting Practices; Optimizing Study Protocols
2013 Speakerpresentations: Building Quality into Trials; Training a High Performing Team;
Effective Communication between Sponsors and Sites; Risk-Based Monitoring Update;
Clinical Trial Compliance and Audit Trends
Drug Information Association (DIA): DIA-HBA (Healthcare Businesswomen’s
Association) Leadership Project: Accelerating leadership talent among women in
regulatory, medical, legal and compliance professions
Alzheimer’s Association: Greater Richmond Chapter: Summarize results of medical
symposiums on Alzheimer’s disease for inclusion into chapter newsletter
New Jersey State Board of Pharmacy: Licensed in New Jersey