Regulatory Affairs Specialist III

Regulatory Affairs Specialist III

REMOTE considered. Possibility of extension.

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 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

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