Administrative Assistant Sales
Resume:
DAVID L ROGERS
Lawrenceville, NJ 08648
****************@*****.***
SUMMARY OF QUALIFICATIONS
. Experienced International Regulatory Affairs Professional seeking
employment in the pharmaceutical industry.
. Experience in pharmaceuticals and medical devices.
. Proficient in Microsoft Word, EXcel, Access, and Sharepoint.
. General understanding of drug development process.
PROFFESIONAL EXPERIENCE
Integra LifeSciences Corporation (December 2008 - Present)
Plainsboro, NJ 08536
Specialist, Regulatory Affairs
(formerly International Regulatory Affairs Associate)
Current Responsibilities
. Prepare regulatory submissions to gain product approval in the Asia-
Pacific countries according to each country's rules and regulations.
. Contributed to the preparation of submissions for Canada, Latin
America, and the European Union.
. Led successful registrations in Taiwan, Indonesia, and Thailand and
have contributed to successes in China, Japan, Singapore, Mexico, and
Brazil.
. Coordinate with Sales & Marketing to determine regulatory strategy.
. Communicate with the company's global facilities to acquire
information for submissions.
. Draft distributor authorization letters and quality agreements using
Microsoft Word.
. Utilize Microsoft Excel daily to maintain product lists and projects.
. Created and maintain Microsoft Access database to track the products
that our Asia-Pacific distributors are authorized to sell and whether
or not they have been legally approved/cleared for marketing in their
respective country.
. Earned promotion for achieving all yearly objectives and exceeding
management's expectations.
. Administrator for the Regulatory Affairs Asia-Pacific Microsoft
Sharepoint site.
. Ship and track distributor correspondence.
. Develop strong rapports with the company's Asia-Pacific distributors
and maintain regular communication with them to ensure submission
success.
. Communicate and conduct meetings with the company's global facilities
to strategize and gather necessary information for product
submissions.
. Communicate with the FDA and prepare Certificates to Foreign
Government.
. Create/revise Standard Operating Procedures (SOPs) as necessary and
conduct SOP training for internal employees to ensure corporate
compliance.
. Read regulatory publications and international news sources to stay
informed about current events in the healthcare industry as well as
the global market.
Barrier Therapeutics, Inc./Stiefel Laboratories, Inc. (May 2007 - December
2008)
Princeton, NJ 08540
R&D Administrative Assistant
. Reported directly to the Chief Scientific Officer (CSO) and managed
his files (digital & hardcopy), literature, memberships, and
appearances.
. Used Microsoft Excel to help manage the Clinical Affairs department's
Trial Master Files and maintained communication with clinical
investigators via email and telephone.
. Utilized Microsoft Access to maintain the Medical Affairs department's
adverse event database.
. Assisted Regulatory Affairs Team in FDA submissions and IND reports.
. Interacted with internal departments to assure that regulatory
submissions were accurate and on time.
. Contributed to various clinical and pharmaceutical development
projects by coordinating meetings, composing presentations, meeting
minutes and action points.
. Managed the company's electronic database of literature, posters, and
reports.
EDUCATION
RIDER UNIVERSITY (Presently)
Lawrenceville, NJ
. Degree: Master's of Business Administration (MBA)
. Status: Part-time
. Graduation Date: May 2012
RUTGERS UNIVERSITY
New Brunswick, NJ
. Degree Earned: Bachelors of Arts (BA)
. Honors: CUM LAUDE
AFFILIATIONS
. Regulatory Affairs Professional Society (RAPS) - active member
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