Regulatory Affairs Specialist III — 6FAP24 : Glbl CMC&Dev Pasteur 9000 (20-00072) – PA – Swiftwater

Candidate to author/review/approve CMC technical documents in ***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 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.
REMOTE considered.
Possibility of extension.
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
Source: Job Diva – Job Listing

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