Sample Resume for Regulatory Affairs Position

SUMMARY
Seeking regulatory affairs position for
biopharmaceutical industry where more than
three years of biological research and
regulatory compliance experience will add
value. Willing to relocate.

PROFILE
Strong regulatory background includes knowledge
of current federal guidelines, FDA/USDA
regulations, SOP preparation, streamlining of
procedures and updated good laboratory
practices.
Superior analytic skills. Currently perform
research for leading molecular biological
laboratory.
Proven communication skills. Accustomed to
working with project teams and providing
research and advice on compliance with federal
laws and regulatory agency guidelines.
Computer skills: MS Project, Word, Excel,
PowerPoint and Access; LIMS (laboratory data
management tool) and Vector NTI (cloning
software). Quick to master new applications.
EXPERIENCE
Research Specialist, ABC Company, Anywhere, USA (2001-present).
Research and develop plant-derived vaccine
products. Also perform optimization of
transgenic plant lines/cells under restricted
and aseptic conditions.
Characterize samples using ELISA and PCR
analysis tools. Perform Western, Northern and
Southern molecular biological assays. Prepare
media for plant tissue and maintain plant
tissue cultures.
Ensure 100% laboratory compliance with federal
laws, FDA, USDA and CVM (Center for Veterinary
Medicine) regulatory guidelines and assess
their impact on products under development.
Research and design new laboratory equipment.
Construct equipment with metal-shop
technicians.
Maximize testing efficiency by streamlining
analyses and documenting repeatable laboratory
SOPs.
Design and facilitate training of research
technicians and student laboratory assistants.
Research Animal Caretaker, ABC Company, Anywhere, USA (2001-2002).
Assured health and quality of laboratory
animals in sterile environment for animal
resource center.
Ensured regulatory compliance with good
clinical practices (GCP) established by federal
law.
Laboratory Technician, ABC Company, Anywhere, USA (1998-2000).
Operated under good laboratory practices (GLP)
to measure air quality in various client
environments.
Analyzed filter samples for total/respirable
dust, cold tar, metal particulates and organic
vapors.
Prepared samples for atomic absorption, ion-
coupled plasma and phase contrast analysis.
Processed analytical data on LIMS (laboratory
information maintenance system) database and
prepared proper documentation for use in
regulatory or legal proceedings.
EDUCATION/TRAINING
Regulatory Affairs Certification (RAC), ABC University, Anywhere, USA (expected
2005).
Bachelor of Science, Biology, ABC University, Anywhere, USA (2002).
Training: Assay validation for pharmaceutical/biopharmaceutical quality
control; Certified Animal Care Program (Level
I/II): and Fundamentals of industrial hygiene
monitoring.