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Regulatory Affairs Specialist
Ref No.: 19-16299
Location: Swiftwater, Pennsylvania
Sunrise System Inc. is currently looking for Regulatory Affairs Specialist in Swiftwater, PA with one of our top client.
 
Job Title: Regulatory Affairs Specialist
Job Id: 19-16299
Location: Swiftwater, PA 18370
Duration: 5 months
Position Type: Hourly contract Position (W2 only)
 
Duties
  • Candidate to author/review/approve CMC technical documents in Client's 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 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
  • Experience with drug/biologics licensure
  • Prior regulatory experience
  • Technical writing experience (CMC experience)
  • Scientific background 
Experience
  • 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
  • Track wise Applications
  • ICH Guidelines
  • GMP experience
  • Experience with drug/biologics licensure preferred
  • Prior regulatory experience 
Required Skills
  • CMC
  • Documentum
  • Excel
  • FDA
  • GMP 
Additional Skills
  • ICH
  • Microsoft Office
  • PowerPoint
  • Regulatory Affairs
  • Track wise
  • Word
  • Chemistry
  • Microsoft Excel
  • Microsoft PowerPoint
  • Microsoft Word
  • Regulatory Documents
  • Writing Experience 
Contact
Pooja Sinha
Direct: (732) 272 - 0316 | Email: pooja.s@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com