Regulatory Affairs Specialist V (5608050)

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.
• Prior regulatory experience.
• Technical writing experience (CMC).
• Scientific background.

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

Tools

Documentum

TrackWise

MS Office

Job description

Regulatory Affairs Specialist V (5608050)

• Contract

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Candidate to author technical documents in Client's internal documentum system. Must have working knowledge of bacterial biologics and regulations pertaining to early and late phase pre-licensure activities. Must have working knowledge of GMPs and application to preparing clinical materials. 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.

Job Responsibilities

• This position is working in the CMC area. Relevant experience is required
• Experience: 3 to 6 years
• Experience with drug/biologics licensure
• Prior regulatory experience
• Technical writing experience (CMC)
• Scientific background

Required 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

For more information, Please contact

Akriti Gupta
Office: 973.967.3409 | Fax: [phone]