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Click here or scroll down to respond to this candidate Candidate's Name
Street Address Castile Avenue Cell Phone: PHONE NUMBER AVAILABLE
Coral Gables, FL Street Address Email: EMAIL AVAILABLE
SENIOR PHARMACEUTICAL PROFESSIONAL
QUALITY ASSURANCE CLINICAL RESEARCH REGULATORY AFFAIRS
Accomplished, results oriented, senior pharmaceutical executive with significant leadership experience
in the medical device, pharmaceutical and clinical research fields. Collaborative management style with
effective interpersonal skills to drive change, cultivate strong relationships, and work cohesively at all
levels and across disciplines within an organization. Successful track record obtaining FDA and
European product approvals.
AREAS OF EXPERTISE
Strategic Planning & Business Analysis Quality Assurance & Regulatory Affairs
New Product Development & Support FDA Communications & cGMPs
Contract Negotiations Laboratory Operations & Management
Business & Pharmaceutical Partner Alliances Preclinical & Clinical Trial Studies
PROFESSIONAL EXPERIENCE
VOISIN CONSULTING INC. Cambridge, MA 2015 to Present
International consulting company assisting clients in product development and communication with
regulators.
Senior Director, Regulatory Science, Drugs and Biologics
Provide international regulatory support and roadmaps for companies in the US and EU. Define and
implement global regulatory strategies in drug development. Write and review regulatory submissions
such as New Drug Applications, Biological License Applications, Investigational New Drug
Applications and Orphan Drug Designation. Obtained first FDA approval of hydroxyurea for use in
pediatric patients with sickle cell anemia and for a combination of amlodipine/celecoxib for patients
with osteoarthritis and hypertension.
PROSOLUS PHARMACEUTICALS, LLC Miami, FL 2013 to 2015
A developer and manufacturer of transdermal delivery systems. Subsidiary of Mission Pharmacal Company.
Vice President of Regulatory Affairs, Quality Control, Quality Assurance & Clinical Research
Managed the Regulatory Affairs, Quality and Clinical Research operations. Responsible for
implementation of regulatory strategies and processes to gain product approvals. Provided guidance to
new product development team and manufacturing group. Served as key contact for regulatory agencies
and external partners. Increased the company s value ultimately resulting in acquisition.
Candidate's Name Resume - Page 2
HERCON PHARMACEUTICALS, LLC Emigsville, PA 2012 to 2013
A developer and marketer of transdermal delivery systems.
Executive Director of Regulatory Affairs, Quality Control& Quality Assurance
Responsible for all quality, clinical research, and regulatory activities. Lead quality and regulatory
efforts for new product development. Charged with upgrading FDA compliance and laboratory
operations. Managed a staff of 11 professionals. Monitored all clinical studies for compliance to GCPs.
Reported to the company President.
ACCU-BREAK PHARMACEUTICALS, INC. Plantation, FL 2003 to 2012
A global developer and provider of innovative pharmaceutical tablet technologies for accurate and
customized dosing of single and combination drug products.
Co-Founder, Chief Operating Officer, and Vice President of Regulatory Affairs
Led all operational infrastructure services, regulatory affairs, and business development activities for
breakthrough technology with broad applications across therapeutic categories, pharmaceutical
segments, formulations, and combinations.
Developed and refined regulatory strategies to ensure compliance and to resolve regulatory issues.
Conducted cGMP inspections of pharmaceutical companies engaged to manufacture or co-develop
products. Reported to the President and was a member of the Board of Directors. Managed a staff up to
10 team members on a matrix basis including accounting, legal, clinical research, and business
development.
Played integral role as co-founder in obtaining the company s initial financing. Wrote business
plan and private placement memorandums and led financial and technical discussions with
investment bankers.
Facilitated corporate product strategy and actively advised customers and partners on regulatory
considerations and approaches as an instrumental member of the senior management product
development team.
Evaluated companies and conducted product screening for future business opportunities.
Influential contributor to a major veterinary enterprise adopting technology for the development
of two products.
Negotiated and reviewed contracts with pharmaceutical partners as co-developers and marketers
of the company s pipeline.
Led sales efforts to win two licensing contracts with pharmaceutical companies located in the US
and Asia.
Collaborated with physician investigators in the design of clinical studies and monitored clinical
research organizations (CROs) for compliance to GCPs, leveraging extensive expertise.
Candidate's Name Resume - Page 3
NOVEN PHARMACEUTICALS INC. Miami, FL 1987 to 2003
A specialty pharmaceutical company engaged in the research, development, manufacture, marketing,
and sale of prescription pharmaceutical products. A US division of Hisamitsu Pharmaceutical
Company, Inc.
Executive Director of Medical & Regulatory Affairs
Selected as the third key professional recruited to this newly formed company, as it rapidly grew from a
start-up position to a fully integrated, $55million pharmaceutical company with 250 employees.
Spearheaded the development and expansion of the quality control, quality assurance, regulatory affairs,
and clinical research departments as the company focused on developing several women s health and
hormonal replacement products, second generation drugs, and the development of products in such
therapeutic areas as CNS, pain management, and cardiovascular. Accountable for a $10 million budget
and offered product development insight in the formation of corporate five- and ten-year strategic plans.
Served as a liaison with the FDA, European Health Authorities, and national/global partners.
Contributed to formulation development advancements. Reported to the CEO.
Designed and conducted preclinical/clinical studies for the entire company product portfolio.
Selected and inspected CROs for specific trials and personally led the evaluation of clinical
sites and investigators for other studies.
Conducted vigorous research and prepared detailed technical documents necessary for filing
approximately 10 INDs, 1ANDA, 4 NDAs, and 3 MAAs with the FDA and European
Regulatory Agencies. Ensured seamless and timely regulatory processing by proactively
anticipating and addressing inquiries, evidenced by minimal regulatory follow-up questions,
including the chemistry, manufacturing and control (CMC) section.
Designed, researched, and drafted the compliant Current Good Manufacturing Practices
documentation system, incorporating the standard operating procedures (SOPs) and standard
testing procedures (STPs), which are still used today. Inspected frequently as a new
company, passing all FDA visits with minimal observations.
Attained FDA approval on four transdermal products currently being marketed and one
transmucosal product. Collaborated with two Big Pharma licensing partners to gain MAA
(Marketing Authorization Application) approval on three products. Led negotiations for
product approvals with the FDA and MAA.
Formed the company s first Clinical Advisory Board for psychotropic medications and
women s health specialties. Identified and recruited industry and academic experts, including
a leader in women s health who convinced the FDA to approve Noven Pharmaceuticals
hormonal replacement patch, which became the lowest dosage available on the market.
KEY PHARMACEUTICALS INC.(N/K/A Schering-Plough Corporation)Miami, FL 1984 to 1987
A $200 million company acquired by Schering-Plough Corporation in 1986 for $826 million.
Quality Control Supervisor
Led all quality initiatives related to the company s product portfolio, including transdermal, solid
dose, and liquids. Managed a staff of 30 in conducting microbiology/raw material/tablets and
transdermal testing.
Candidate's Name Resume - Page 4
CD MEDICAL INC. (formerly Cordis Dow Corporation) Miami Lakes, FL 1979 to 1984
A manufacturer of artificial kidneys and joint venture of Cordis Corporation and the Dow Chemical
Corporation between 1974 and 1983, becoming a subsidiary of Dow Chemical Company in 1983.
Quality Assurance Department Head
Quality Control Biological Laboratory Supervisor
Developed cell culture and hemolysis assays for determining the biocompatibility of polymers to
be used in medical devices.
EDUCATION & PUBLICATIONS
BACHELOR OF SCIENCE
Major: Biological Science, Minor: Chemistry
FLORIDA STATE UNIVERSITY
Tallahassee, FL
CO-AUTHOR
A Double-Blind Evaluation of Transdermal Oestradiol versus Placebo in the Treatment of Post-Menopausal
Symptoms. European Journal of Clinical Research 1996:8:219-234.
BOARD MEMBERSHIPS
Accu-Break Pharmaceuticals Inc., 2004 2016
SoLapharm Inc., 2005 2007
PharmaNet Development Group Inc., 2002 2007
(A publicly held clinical research organization)
Appointed to the Audit, Compensation and Nominating Committees
PROFESSIONAL AFFILIATIONS
Regulatory Affairs Professionals Society
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