MedFocus Regulatory Affairs Specialist IV (CMC) in Pennsylvania

Job Description: A Regulatory Affairs Specialist IV (CMC ) is needed for a 5-month contract position at major pharma company in Northeast.

Duties:

  • Candidate to author technical documents in Sanofi's internal documentum system.

  • Must have working knowledge of bacterial biologics and regulations pertaining to pre and post licensure activities related to CMC.

  • 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.

Education and Experience:

  • BS in Biology/Chemistry or related field

  • 3 to 6 years of experience; 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

  • GMP experience

  • Experience with drug/biologics licensure

  • Prior regulatory experience

Skills:

  • CMC/ Regulatory writing experience Scientific background, vaccines preferred

  • Microsoft Office (Word, Excel, PowerPoint)

  • Documentum Applications

  • Trackwise Applications

  • ICH Guidelines

Please send resume to jobs@inventivhealth.com

Min Salary: $0.00

Max Salary: $0.00

State: PA