Regulatory Affairs Specialist III

Swiftwater, PA

Posted: 10/08/2019 Industry: Biotech/R&D/Science Job Number: 49630

  • Candidate to author/review/approve CMC technical documents in internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities.   
  • Must have working knowledge of biologic/drug regulations (FDA, ICH, EU,  etc) related to CMC.   
  • Provide regulatory guidance for development  projets, post-approval CMC changes/variations.  
  • Must have working knowledge of GMPs.   
  • Must be well-organized, work with minimal management and meet aggressive timelines.  
  • Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.    
  • **This position is working in the CMC area.   
  • Relevant experience is  required   
  • Experience  with drug/biologics  licensure 
  • Prior  regulatory experience  
  • Technical writing experience (CMC experience) 
  • Scientific background 

  • CMC/ Regulatory  writing  experience   
  • 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3 
  • Scientific background, vaccines preferred 
  • Microsoft Office (word, excel,  powerpoint) 
  • Documentum/ Veeva Applications 
  • Trackwise  Applications 
  • ICH Guidelines 
  • GMP experience 
  • Experience with drug/biologics licensure preferred 
  • Prior  regulatory experience  

  • BS in Biology/Chemistry or related field 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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