Regulatory Affairs CMC

ArtechInformationSystemLLC

Westborough, MA, United States contract

Posted: December 23, 2015

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Quick Summary

Perform general Regulatory Affairs Chemistry Manufacturing and Controls work including dossier and document preparation for clients.

Required Skills

Regulatory Affairs CMC Dossier Preparation Document Preparation Regulatory Compliance Global Regulatory Strategies Regulatory Submissions Regulatory Compliance Administrative Support Interact cross-functional teams Project Support

Job Description

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

Best Regards,

Anuj Mehta

973-967-3402

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