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.
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 )
Experience with drug/biologics licensure
Prior regulatory experience
CMC/ Regulatory writing experience Scientific background, vaccines preferred
Microsoft Office (Word, Excel, PowerPoint)
Please send resume to firstname.lastname@example.org
Min Salary: $0.00
Max Salary: $0.00