Regulatory Affairs CMC

artechinformationsystemllc
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📍 MA📍 Westborough📍 Westborough, MA, United States📍 usContract

About this role

Company 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

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.


Qualifications

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


Additional Information

Best Regards,

Anuj Mehta

973-967-3402




 


Frequently Asked Questions

Is the salary disclosed for the Regulatory Affairs CMC position at artechinformationsystemllc?
The salary for this Regulatory Affairs CMC role at artechinformationsystemllc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs CMC position at artechinformationsystemllc located?
This Regulatory Affairs CMC role at artechinformationsystemllc is based in MA, Westborough, Westborough, MA, United States, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs CMC role at artechinformationsystemllc full-time or part-time?
This is listed as a Contract position. It is posted as a Regulatory Affairs CMC role at artechinformationsystemllc.
How do I apply for the Regulatory Affairs CMC position at artechinformationsystemllc?
Click the "Apply Now" button on this page. You will be redirected to artechinformationsystemllc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Regulatory Affairs CMC job at artechinformationsystemllc posted?
This Regulatory Affairs CMC position at artechinformationsystemllc was posted on Dec 23, 2015. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs CMC
artechinformationsystemllc
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