Senior Regulatory Affairs Specialist (CMC/Biologics)

Artech Information System LLC; Swiftwater (Monroe County); On-site; USD 90,000 - 120,000; Full time

Job summary

An IT staffing company in the US is seeking a Regulatory Affairs Specialist V to author technical documents within the internal documentum system. The right candidate should have a strong scientific background, particularly in bacterial biologics, and knowledge of GMP standards relevant to clinical materials. Additionally, 3–6 years of regulatory experience in drug/biologics licensure is essential. Candidates should possess excellent writing and analytical skills and should be able to work independently under aggressive timelines.

Qualifications

• 3 to 6 years relevant experience in CMC.
• Must have working knowledge of bacterial biologics and regulations.
• Must be organized and meet aggressive timelines.

Responsibilities

• Author technical documents in internal documentum system.
• Work in the CMC area related to drug/biologics licensure.
• Utilize strong writing and analytical skills.

Skills

CMC/Regulatory writing experience

Scientific background, vaccines preferred

Microsoft Office (Word, Excel, PowerPoint)

Documentum Applications

Trackwise Applications

ICH Guidelines

GMP experience

Experience with drug/biologics licensure

Prior regulatory experience

Education

BS in Biology/Chemistry or related field

Job description

An IT staffing company in the US is seeking a Regulatory Affairs Specialist V to author technical documents within the internal documentum system. The right candidate should have a strong scientific background, particularly in bacterial biologics, and knowledge of GMP standards relevant to clinical materials. Additionally, 3–6 years of regulatory experience in drug/biologics licensure is essential. Candidates should possess excellent writing and analytical skills and should be able to work independently under aggressive timelines.