Regulatory Affairs CMC

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:

• Perform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including dossier and document preparation for various commercial and/or development product applications.
• Support regulatory activities for the strategies aligned with Health Authority requirements from a global perspective, and supporting the on-time submission of regulatory submissions.
• Additional duties may include regulatory compliance administrative support
• Coordination with cross functional department personnel from regulatory, quality, and manufacturing sites.
• Provide support for other CMC projects and tasks as needed.

Basic

Qualification:

• Bachelor's degree with 2 years experience in a Regulatory Affairs related role
• Fluency in the understanding and format of the Common Technical Document (CTD)
• Authoring experience of CTD Module 2 & Module 3 sections
• Excellent writing skills
• Basic understanding of pharmaceutical manufacturing processes