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Regulatory Project Manager Resume Example

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REGULATORY PROJECT MANAGER
Summary
Versitle Clinical Research and Regulatory Affairs professional with over 11 years of experience serving Pharmaceutical, Biotechnology and Contract Research Organizations (CRO) industries. Successful at starting Phase i to Phase III clinical studies utilizing medical writing and negotiation skills with regulatory and etihical review teams. Expertise in managing clinical trial projects and activities from startup to close-out and submission to FDA.
Skills
  • Electronic Submissions/eCTD
  • DocuBridge submission tools
  • Technical requirements
  • Lifecycle management
  • Submission Validation Requirements
  • Submission Planning/Strategy
Experience
Regulatory Project Manager
July 2016 to January 2017 B&H Consulting － Somerville, NJ
  • Trained Project Management staff on eCTD Module 1 Version 3.2 teaching what sections are being added, moved or deleted from Module 1.
  • Also reached on the new Module 1 metadata requirements.
  • Manage/lead eCTD publishing to ensure compliance with regulatory standards and requirements.
  • Managed operational activities related to global pharmaceutical companys Annual Report submissions; including the preparation of FDA forms and cover letter, conducting final release of the annual report, tracking of submissions and management of submission schedules and compliance.
CRA/IND Specialist
December 2015 to January 2016 Aerotek － Philadelphia, PA
  • Consultant for a startup radiopharmaceutical company advising on the regulatory submission requirements for early Phase I clinical trials.
  • Coordinated two exploratory Investigational New Drug Applications seeking approval to conduct medical imaging trials with an academic partner, the University of Pennsylvania.
  • Prepared the informed consent form and clinical research forms for both trials.
  • Trained in Clinical Monitoring processes.
Senior Associate
June 2013 to August 2015 Accenture － Berwyn, PA
  • Reviewed components of US regulatory submissions for 21 CFR compliance issues to arise clients on submission content avoiding of deficiency letters from the FDA review divisions.
  • Successfully submitted over 10 initial Investigational New Drug (IND) applications all in various sizes and complexity based on the client's strategy.
  • Provided input into the strategy of lifecycle submissions ensuring that the FDA viewed the most current version of submission documents using a regulatory submission review software tool.
  • Stellar performer and quick learner of software used in the field of Regulatory Affairs.
  • Given high honors on an annual performance review competing against other employees at my career level.
Patient Informed Consent Specialist
April 2008 to July 2009 ClinForce, LLC － Ambler, PA
  • Wrote, reviewed and submitted informed consent forms (ICF, Assent, HIPPA) for Vaccine and Infectious Disease clinical trails.
  • Supported the multi-functional clinical trial teams with IRB submission and GCP requirements to ensure the approval to begin or amend a clinical trial.
  • Assisted a Patient Recruitment Specialist in the submission of Promotional Material to the central IRB Review Board to help a stagnant trial for an HIV medication recruit more subjects.
  • Awarded by sponsor's management team in the quick turnaround of subject enrollment efforts for the trial.
Regualtory Specialist
November 2007 to January 2008 INC Research － New Hope, PA
  • Member of a multi-functional clinical trial team responsible for the advisement and submission of essential regulatory documentation to Institutional Review Boards.
  • Also assisted the Senior Regulatory Affairs Specialist in the compilation of special regulatory submission projects to the FDA in paper or electronic format.
  • Focused on the Therapeutic Area of Infectious Disease assisting with the development of various dosage forms.
  • Managed the Trial Master File archive that Infectious Disease assisting with the development of various dosage forms.
  • Managed the Trial Master File archive that was both paper and electronic forms.
  • Assisted the company in becoming more electronic with their records and helping to solve the problem of too little space for the paper archive.
Document Control Specialist
April 2006 to August 2007 Tengion, Inc － Norristown, PA
  • Worked within the Quality Assurance department to effectively manage the company's document control system.
  • Reorganized the paper system to be compliant with federal regulatory requirements as well as protecting the asset from loss during a disaster.
  • Presented to senior management about switching the document system to electronic helping to solve the issue of lost paper versions and shortening the amount of time needed to review and make changes to documents.
  • Earned an annual bonus for stellar performance in document control helping the department and the organization meet its milestones.
Regulatory Document Associate
February 2005 to April 2006 Aerotek － West Chester, PA
  • Super user of the client's electronic document control software (EDMS) program assisting in the creation, formatting, review and electronic approval of Regualtory and Quality Assurance documentation to become 21 CFR Part 11 compliant.
  • Gave software demos to new users and replied to e-mail questions regarding the software's use.
  • Assisted the Regulatory Document Manager in managing the conversion from paper to electronic documentaton.
Global Regulatory Archive Assistant
January 2005 to February 2006 Kelly Services － Malvern, PA
  • Part of a project team for a biotechnology company whom made the decision to move their paper global regulatory submission archive to an electronic library making it easier for regulatory Affairs staff to find information and perform due diligence activities.
  • Scanned the paper submisisons to an Adobe PDF file and added the electronic submissions to an eDOC document repository using Documentum.
  • Created an Excel spreadsheet list of past Safety (Medwatch and CIOM) submissions assisting in creating an electronic database.
Education and Training
M.S : Quality Assurance and Regulatory Affairs, 2009 Temple University － Philadelphia, PA Quality Assurance and Regulatory Affairs
B.S : Business Management, 2004 West Chester University － West Chester, PA Business Management
Activities and Honors
  • Member, Regulatory Affairs Professional Society (RAPS), March 2015 - Present
  • Member, Drug Information Association (DIA), May 2016 - Present
  • Member, American Medical Writers Association (AMWA), March 2017 - Present
Skills
21 CFR Part 11, Academic, Adobe, advisement, biotechnology, clinical research, clinical trials, Consultant, content, electronic conversion, client-centric, regulatory documentation, Documentum, due diligence, GCP, , IND, Project Management, Quality Assurance, quick learner, Regulatory Affairs, Safety, strategy, teaching, 
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Resume Overview

Companies Worked For:

  • B&H Consulting
  • Aerotek
  • Accenture
  • ClinForce, LLC
  • INC Research
  • Tengion, Inc
  • Kelly Services

School Attended

  • Temple University
  • West Chester University

Job Titles Held:

  • Regulatory Project Manager
  • CRA/IND Specialist
  • Senior Associate
  • Patient Informed Consent Specialist
  • Regualtory Specialist
  • Document Control Specialist
  • Regulatory Document Associate
  • Global Regulatory Archive Assistant

Degrees

  • M.S : Quality Assurance and Regulatory Affairs , 2009
    B.S : Business Management , 2004

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