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Regulatory Affairs Specialist Resume Example

Resume Score: 80%

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REGULATORY AFFAIRS SPECIALIST
Skill Highlights
  • Strong project management, organization and collaboration skills
  • Proficient with quality computer systems, enterprise systems, Adobe and Microsoft Office including Word, Excel, Power Point, and Outlook
  • Adaptive team player
  • Strong customer focus; maintain relationships while continuously meeting project timelines
  • Excellent written and verbal communication 
  • Detail oriented
Professional Experience
Regulatory Affairs Specialist
March 2015 to January 2016
Baxter Healthcare Corporation - Bloomington, IN
  • Responsible for providing regulatory support across three (3) separate Baxter facilities, including participating on cross-functional teams  
  • Authored regulatory project plans and provided support to Pharma Partners seeking major market approval of their drug application (US, Europe, Canada)    
  • Coordinated and wrote global regulatory applications.  
  • Maintained regulatory submission files in accordance with ICH and regulatory requirements.  
  • Responded to agency deficiency requests within strict timelines
  • metrics
  • provided ongoing support to junior level associates to help develop their knowledge of regulations and procedures
Regulatory Affairs Senior Associate
February 2012 to March 2015
Baxter Healthcare Corporation - Bloomington, IN
  • Participated on a cross-functional team to support implementation of a Master Diluent Program. Provided regulatory risk evaluation and guidance to ensure compliance with governing regulations and to mitigate deficiencies within the design space.  
  • Coordinated and wrote global regulatory applications; responsible for lifecycle maintenance of eight (8) Drug Master Files (DMFs), Site Master File and Validation Master Plan.    
  • Maintained regulatory submission files in accordance with ICH and regulatory requirements.  
  • Lead the effort to convert BPS DMFs into electronic Common Technical Document (eCTD) format; successfully converted four (4) out of eight (8) DMFs and submitted to FDA in eCTD format within established timelines.    
  • Responded to agency deficiency requests within strict timelines.    
  • Authored project plans and provided support to Pharma Partners referencing BPS DMFs in accordance with established timelines.  
  • Perform change control assessment and provide notification of proposed facility changes for regulatory impact to approved Pharma Partner marketing applications.  
  • Provided guidance and coaching to team members for international filing support.
Quality Associate II - Stability Program Lead
August 2008 to February 2012
Baxter Healthcare Corporation - Bloomington, IN
  • Successfully managed the execution and maintenance of stability programs for 15 Pharma Partners and 3 Proprietary products; maintained 99.4% on-time delivery and generated ~$2.5M annually.
  • Wrote and maintained stability protocols and project plans used to support regulatory submissions for Pharma Partners and Proprietary products.   
  • Collaborated with Regulatory Affairs personnel to ensure accuracy and completeness of Proprietary stability study data reflected in regulatory documents.  
  • Assisted in internal, client and regulatory audits; compiled audit observation responses and completed audit response action items in an accurate and timely manner.
Quality Associate I - Microbiology Analyst
September 2006 to August 2008
Baxter Healthcare Corporation - Bloomington, IN
  • Authored exception and investigation reports for deviations with the potential to impact the integrity of finished product.  
  • Coordinated and performed bioburden method validations, bacteriostasis/fungistasis sterility test method validations, sterility testing of finished product and stability samples, in-process bioburden testing, microorganism identifications, and environmental monitoring of classified areas.  
  • Trained new access users for laboratory support software systems.
Education and Training
Bachelor of Arts : Biology, 2006Indiana University - Bloomington, IN, USA
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Resume Overview

Companies Worked For:

  • Baxter Healthcare Corporation

School Attended

  • Indiana University

Job Titles Held:

  • Regulatory Affairs Specialist
  • Regulatory Affairs Senior Associate
  • Quality Associate II - Stability Program Lead
  • Quality Associate I - Microbiology Analyst

Degrees

  • Bachelor of Arts : Biology , 2006

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