PHARMACEUTICAL REGULATORY AFFAIRS MANAGEMENT

Proven Track Record in Domestic, Canadian, and EU Submission Strategy; Expertise

in Domestic and OUS Drug Submission Writing and Negotiation with Domestic and O
US Health Agencies; and Experience with Domestic Clinical Trial Management
Talented, accomplished, and results-oriented senior management professional with
over 20 years of experience and demonstrated success in domestic and internatio
nal regulatory affairs in the pharmaceutical industry. Strong background in qual
ity compliance, business process reengineering, and process validation. Proven a
bility to synthesize, review, and analyze complex data, contributing valuable in
sight to enhance the decision-making process. Highly regarded for the ability to
drive processes, motivate cross-functional teams, and work well under pressure
to manage and meet multiple project deadlines.
CORE COMPETENCIES
- Continuous Process Improvement
- Policy/Procedure Development
- Quality Management Systems
- Test Method Development
- Validation and Document Control - Resource and Budget Management
- Risk Assessment and Mitigation
- Program and Project Management
- Team Collaboration and Leadership Skills
- Strategic Planning and Tactical Execution - Effective Contract Negotiations
- Advertising and Promotion Review
- Quality Assurance and Control
- Compliance/Regulatory Standards
- Strong Problem-Solving Abilities

CAREER HIGHLIGHTS
* Strategized, written, and submitted more than 300 drug submissions of various
types and sizes worldwide, and five 501(k) applications, annual reports, and sup
plements.
* Eliminated contract regulatory organizations (CRO) by building a regulatory af
fairs department from the ground up, producing annual cost savings of about $2 m
illion.
* Developed and validated a new, more reliable stability-indicating test method,
replacing animal testing, for a drug product sold in Europe; received approval
for immediate labeling in less than the normal time to prevent stockout.
* Initiated a strategy to submit stability data for the product manufactured, av
oiding an imminent stockout due to lack of regulatory approval.
* Identified regulatory and R&D documents, created a document control system, re
constructed all the latest approved specifications and test and manufacturing me
thods, and compiled into Dentsply format.
* Took over a failed Phase I safety trial from a regulatory consultant, develope
d new protocols to fulfill the FDA's requirements, and received approval for cli
nical trial to proceed.
* Played key role in renewing expired contract with contract manufacturer by upg
rading old, existing product NDAs.
PROFESSIONAL EXPERIENCE
DENTSPLY PHARMACEUTICAL, York, Pennsylvania 2006-12/2010
One of the largest professional dental products companies in the world with faci
lities in 38 nations, serving 120+ countries.
Worldwide Pharmaceutical Regulatory Affairs Manager
Write and supervise the writing of entire Module 3 sections of CTD documents and
CMC content. Manage pediatric clinical trials. Strategize, write, and submit a
pediatric IND and amendments, EU drug submissions, and US/ROW drug submission st
rategies. Serve as senior regulatory employee in the Pharma division. Assume bud
get responsibility for RA, Pharma R&D, and Pharma Clinical. Supervise 3 staff an
d all RA, R&D/CMC, and clinical consultants. Participate or manage HA dossier au
dits and pharmacovigilance audits worldwide. Oversee submission publication in U
S CTD and NEES CTD formats.
* Reduced annual regulatory consultant costs by $2 million by bringing all regul
atory submission activities in-house and building a regulatory affairs team from
the ground floor.
* Successfully brought all CMC activities in-house, including strategy and docum
ent content generation; fulfilled outstanding CMC promises to various health age
ncies which, in some cases, were outstanding by 5 years.
* Designed and executed relevant R&D strategy to reduce OOS and manufacturing do
wntimes and increase shelf life, generating initial CTD Module 3S and initial ov
erall quality summaries.
* Effectively negotiated with FDA to fulfill pediatric use requirement with off-
label Phase II clinical trial since no on-label pediatric patients exist.
* Directly contributed to submitting approximately 10 drug submissions of variou
s types globally (some modest in size) per month over the last 3 years.
* Initiated and instituted regulatory affairs and R&D strategy to eliminate $500
,000 of cost of sales for one product.
MERETEK DIAGNOSTICS GROUP, Lafayette, Colorado 2000-2005
Subsidiary of Otsuka America Pharmaceutical, Inc., leading healthcare company co
mprised of 99 companies and approximately 31,000 people around the world with an
nual revenue of more than $7 billion.
Director, Regulatory Affairs and Quality
Hired to implement a commercial quality system for a combination drug and device
company from the ground floor. Served as project manager for a pediatric clinic
al trial. Managed the writing of the protocol, case report form, informed consen
t forms, biochemical test methods, sample shipping instructions, clinical contra
cts with the sites, site initiation visits, and CRO selection, and performed QA
audits of the clinical trial. Assumed responsibility for the QC Lab, contract ma
nufacturers, and for all product development work. Hired and set up all function
al areas from inception to completion.
* Designed and implemented the integrated pharmaceutical and device change contr
ol systems.
* Requested and received a request for pediatric studies from FDA, making produc
t eligible for pediatric exclusivity.
* Facilitated a 6-month extension of the use-patent for the drug portion of the
diagnostic product when the pediatric NDA clinical supplement was approved.
* Rewrote and created drug and device Quality Systems from the ground floor.
* Successfully led 3 FDA audits, including a rare IDE audit, with no FDA 483 obs
ervations.
* Led company to achieve the ISO 13488 certification process.
GEBAUER COMPANY, Cleveland, Ohio 1995-2000
Internationally recognized medical device manufacturer.
Director, Regulatory Affairs and Quality
Directed all Quality, QC, and chemical R&D, Document Control, and Regulatory Aff
airs activities including writing batch records, process validation, and test me
thod validation protocols and reports, as well as API, excipient, and finished p
roduct and packaging specifications. Identified requirements and wrote all regul
atory submissions including all CMC documentation. Actively participated in fore
ign drug submissions for Chile, Egypt, and Israel. Quickly responded to 483s and
warning letters from FDA and effectively handled Class 2 recall. Created and ma
naged budget for Regulatory, QA, QC, and Doc Control. Served as Health Agency (F
DA) and other government agency audit escort.
* Built QA/RA functional areas from the ground floor and created a document cont
rol function, developing specifications and accurate and usable batch records.
* Influenced the company president to create an engineering department since cus
tom manufacturing equipment was needed before the manufacturing processes could
be validated.
* Submitted 510(k) applications for all unapproved drug products and made them a
ll cleared devices, which was permitted per interoffice agreement between CDER a
nd CDRH.
* Hired as Manager of QA and RA and promoted to Director level within 2 years.
EARLY CAREER: Includes positions as Quality Control Supervisor, Ben Venue Labora
tories; Pharmaceutical QC Supervisor/Acting QC Manager and QC Laboratory Chemist
, Pitman Moore.

EDUCATION
UNIVERSITY OF AKRON, SCHOOL OF LAW - Akron, Ohio
Juris Doctor (JD), Specialized in Administrative Law; Thesis in Food & Drug Law,
2000
UNIVERSITY OF MISSOURI, ROCKHURST COLLEGE - Kansas City, Missouri
Post-Graduate Courses in Chemistry and Computer Science
UNIVERSITY OF KANSAS - Lawrence, Kansas
Bachelor of Science in Chemistry
Bachelor of Arts in Economics
AFFILIATION
Member, Regulatory Affairs Professional Society (RAPS)