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director of regulatory affairs resume example with 15+ years of experience

Jessica
Claire
resumesample@example.com
(555) 432-1000,
, , 100 Montgomery St. 10th Floor
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Summary

Director of regulatory affairs with 15 years of experience in oncology drug development looking to join a team that is passionate about advancing new treatment options for cancer patients.

Skills
  • Managing FDA, EMA Communications
  • Lifecycle Management
  • Regulatory Project Management
  • Grant Writing Experience (NIH, SBIR)
  • Clinical research administration, data collection, and data analysis
  • Software Experience: ETMF, EMR, CTMS
  • Exceptional communication, organization, and time management skills
Education and Training
SAN DIEGO STATE UNIVERSITY San Diego, CA Expected in 01/2008 Master of Public Health : Epidemiology - GPA :
POINT LOMA NAZARENE UNIVERSITY San Diego, CA Expected in 01/2006 Bachelor of Arts : Biology - GPA : Received full tuition honors scholarship, 2002-2006
Experience
Cello Health - Director of Regulatory Affairs
Midland Park, NJ, 06/2017 - Current
  • Oversee regulatory affairs activity for a small biotech company, including preparing IND submissions, liaison with FDA by leading formal meetings and phone/email communications, and life cycle management for several oncology products

Key Accomplishments:

  • Successfully moved a novel biologic from discovery to an ongoing phase 1/2 clinical trial including managing the IND-enabling toxicology study, pre-IND meeting with FDA CBER, and full IND submission which was approved following the initial submission
  • Productive and collaborative EOP2 meetings with FDA CDER for an orphan drug combination drug/device (drug primary MOA) which is now in Phase III clinical trials
American College Of Surgeons - Independent Consultant
Chicago, IL, 08/2015 - 06/2017
  • Prepare pre-clinical grant applications and project management support for early R & D efforts
  • Develop protocols, consent forms and regulatory documents for a new oncology product

Key Accomplishment:

  • Led a successful pre-IND meeting with FDA CBER division
Children's National Medical Center - Data Manager
Fulton, MD, 12/2015 - 06/2017
  • Project management for translational research program
  • Compiled data and progress reports for preclinical research studies
Moores Cancer Center At UC San Diego Health - Senior Clinical Research Data Manager
City, STATE, 09/2012 - 12/2015
  • Built and managed queries, exports, and analysis reports for cancer center investigators and administration
  • Partnered with cross-functional teams on data organization, storage, access and mapping to ensure NCI requirements were met.
  • Created and facilitated in-house training program for database users.
Moores Cancer Center At UC San Diego Health - Clinical Trials Regulatory Specialist
City, STATE, 08/2011 - 09/2012
  • Managed upkeep of regulatory electronic and hard copy filing systems and archives.
  • Developed standardized templates and training materials for IRB submissions.
  • Enforced regulatory affairs department compliance with agency requirements.
  • Updated in-depth trackers of approvals and submissions.
  • Monitored regulatory change required by new and revised laws and regulations, communicating complex protocols and determining operational impacts.
  • Hired team members and trained in collaborative team environment.
Moores Cancer Center At UC San Diego Health - Clinical Trials Regulatory Coordinator
City, STATE, 09/2008 - 08/2011
  • Prepared IRB applications, consent forms, and essential documents for over 50-60 cancer trials
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
  • Demonstrated leadership by making improvements to work processes and helping to train others.
Moores Cancer Center At UC San Diego Health - Clinical Research Coordinator Intern
City, STATE, 01/2007 - 06/2008
  • Coordinated research activities for 160 participants in the (NCI) funded National Lung Screening Trial
  • Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Community Involvement

VISTA GRANDE ELEMENTARY SCHOOL – San Diego, CA 09/19 – Present

Voting Member, Site Governance Team

VISTA GRANDE FOUNDATION – San Diego, CA 09/19 – Present

Voting Member

UPLIFT SAN DIEGO – San Diego, CA 09/09 – 06/12

Volunteer Tutor

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Resume Overview

School Attended

  • SAN DIEGO STATE UNIVERSITY
  • POINT LOMA NAZARENE UNIVERSITY

Job Titles Held:

  • Director of Regulatory Affairs
  • Independent Consultant
  • Data Manager
  • Senior Clinical Research Data Manager
  • Clinical Trials Regulatory Specialist
  • Clinical Trials Regulatory Coordinator
  • Clinical Research Coordinator Intern

Degrees

  • Master of Public Health
  • Bachelor of Arts

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