Regulatory Affairs Specialist III
  • East Hanover, New Jersey, US
  • +914043515100
464 Days ago
Job Description

Roles and Responsibilities:

  • Candidate to author/review/approve CMC technical documents 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 projects, 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.

Job Skills:

  • vaccines preferred Microsoft Office (word, excel, powerpoint) Documentum/ Veeva Applications Trackwise Applications ICH Guidelines GMP experience
  • CMC
  • Documentum
  • Excel
  • FDA
  • GMP

Education & Experiences:

  • BS in Biology/Chemistry or related field Skills and Experience
  • 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
  • Experience with drug/biologics licensure preferred Prior regulatory experience
  • NA

Required Skills
  • Regulatory Affairs Specialist III

  • 3 Years of Experience

  • NA

Working Hours / Week
  • 40h