LiveCareer
LiveCareer
  • Dashboard
  • Jobs
  • Resumes
  • Cover Letters
  • Resumes
    • Resumes
    • Resume Builder
    • Resume Examples
      • Resume Examples
      • Nursing
      • Education
      • Administrative
      • Medical
      • Human Resources
      • View All
    • Resume Search
    • Resume Templates
      • Resume Templates
      • Nursing
      • Education
      • Medical
      • Human Resources
      • Customer Service
      • View All
    • Resume Services
    • Resume Formats
    • Resume Review
    • How to Write a Resume
    • CV Examples
    • CV Formats
    • CV Templates
    • Resume Objectives
  • Cover Letters
    • Cover Letters
    • Cover Letter Builder
    • Cover Letter Examples
      • Cover Letter Examples
      • Education
      • Medical
      • Human Resources
      • Customer Service
      • Business Operations
      • View All
    • Cover Letter Services
    • Cover Letter Templates
    • Cover Letter Formats
    • How to Write a Cover Letter
  • Jobs
    • Mobile App
    • Job Search
    • Job Apply Tool
    • Salary Calculator
    • Business Letters
    • Job Descriptions
  • Questions
  • Resources
  • About
  • Contact
  • 0Notifications
    • Notifications

      0 New
  • jane
    • Settings
    • Help & Support
    • Sign Out
  • Sign In
Member Login
  • LiveCareer
  • Resume Search
  • Director of Drug Regulatory Affairs
Please provide a type of job or location to search!
SEARCH

Director of Drug Regulatory Affairs Resume Example

Resume Score: 100%

Love this resume?Build Your Own Now
DIRECTOR OF DRUG REGULATORY AFFAIRS
Executive Profile
Highly motivated and result driven Regulatory Affairs professional, with the knowledge about FDA principles and strategies to be an effective Regulatory representative.   
Core Accomplishments

CERTIFICATIONS:

  • Regulatory Affairs Certification (RAC-US) - Granted November 2001
  • Certified Quality Auditor (ASQ) - Granted December 2016
 
PUBLICATIONS:
  • Mitchel J, V. Hayes, Shatzoff M, Park GD: The Critical Path Initiative Meets Medical Devices. Applied Clinical Trials 2007;16:3; 48-54.
  • Shatzoff M, Park G., Verela F: Electronic Submissions. RAPS Focus 2007
Professional Experience
Director of Drug Regulatory Affairs05/2006 to CurrentTARGET HEALTH INC.New York, NY
  • Authorized FDA contact regarding regulatory activities and applications.
  • Resolve issues, inquiries, and deficiency letters with regulators.
  • Facilitate and manage company communications with Regulatory Agencies, including management of Agency meetings.
  • Oversee the planning, implementation, and tracking of both short and long term projects and coordinate the establishment and execution of specified deliverables.
  • Lead regulatory teams with regard to regulatory issues and requirements.
  • Develop regulatory strategies for projects.
  • Manage submissions to meet timelines.
  • Maintain a high level of knowledge of regulations and regulatory processes.
Manager of Drug Regulatory Affairs10/2002 to 02/2006SANOFI-AVENTISNew York, NY
  • Prepare, review and maintain applications and submissions, which support New Drug Applications (NDA), Biological License Applications (BLA) and Investigational New Drug Applications (INDs).
  • Maintain global electronic databases.
  • Participate in project teams for regulatory pathways, strategies and research requirements related to NDA and BLA product lifecycle.
  • Write Standard Operating Procedures (SOPs).
  • Facilitate training of associates and support personnel.
  • Maintain all of the responsibilities of a Drug Regulatory Affairs Specialist.
Senior Associate of Drug Regulatory Affairs12/1999 to 07/2001Ivax Pharmaceutical, Inc.Northvale, New Jersey
  • Facilitate training of associates and support personnel.
  • Prepare, review and maintain the CMC sections of Abbreviated New Drug Applications (ANDAs) and FDA response letters in accordance with FDA regulations and regulatory guidelines.
  • Advise support groups of documents necessary for inclusion in drug applications/ responses.
Quality Control Microbiologist04/1996 to 09/1998PFIZER, INCBrooklyn, NY
  • Conduct studies to support microbiological/ sterility method validation reports and write study reports for new drug applications (NDA).
  • Conduct media fill studies and write study reports.
  • Conduct sterilization validation studies for terminally sterilized drug products and write study reports.
  • Write Standard Operating Procedures (SOPs).
Education
Master of Science Degree of Drug Regulatory AffairsSeptember 2003Long Island UniversityBrooklyn, NY
Bachelor of Science Degree: BiologyJune 1994Northeastern UniversityBoston, MABiology
Master of SciencepresentLehigh UniversityPA
Professional Affiliations
Regulatory Affairs Professional Society (RAPS) - Since 1998
Drug Information Association (DIA) - Since 2002
American Society for Quality (ASQ) - Since 2005
Skills

Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Outlook, Microsoft Powerpoint, Documentum, eCTDXpress, Electronic Gateway Management, ISI Toolbox, SPL Template Management

Build Your Own Now

DISCLAIMER

Resumes, and other information uploaded or provided by the user, are considered User Content governed by our Terms & Conditions. As such, it is not owned by us, and it is the user who retains ownership over such content.

Resume Overview

Companies Worked For:

  • TARGET HEALTH INC.
  • SANOFI-AVENTIS
  • Ivax Pharmaceutical, Inc.
  • PFIZER, INC

School Attended

  • Long Island University
  • Northeastern University
  • Lehigh University

Job Titles Held:

  • Director of Drug Regulatory Affairs
  • Manager of Drug Regulatory Affairs
  • Senior Associate of Drug Regulatory Affairs
  • Quality Control Microbiologist

Degrees

  • Master of Science Degree of Drug Regulatory Affairs September 2003
    Bachelor of Science Degree : Biology June 1994
    Master of Science present

Create a job alert for [job role title] at [location].

×

Advertisement

Similar Resumes

View All
Director-of-Regulatory-Affairs-resume-sample

Director of Regulatory Affairs

Global Clinical Trial Consulting Firm

Boston, Massachusetts

Regulatory-Affairs-CMC-Director-resume-sample

Regulatory Affairs CMC Director

Downingtown, Pennsylvania

Chair,-Regulatory-Affairs-Committee-resume-sample

Chair, Regulatory Affairs Committee

Fox Rehabilitation

Dunellen, New Jersey

About
  • About Us
  • Privacy Policy
  • Terms of Use
  • Sitemap
Help & Support
  • Work Here
  • Contact Us
  • FAQs
Languages
  • EN
  • UK
  • ES
  • FR
  • IT
  • DE
  • NL
  • PT
  • PL
Customer Service
customerservice@livecareer.com
800-652-8430 Mon- Fri 8am - 8pm CST
Sat 8am - 5pm CST, Sun 10am - 6pm CST
  • Stay in touch with us
Site jabber winner award

© 2021, Bold Limited. All rights reserved.