Regulatory CMC Associate Manager

artechinformationsystemllc
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šŸ“ East HanoveršŸ“ East Hanover, NJ, United StatesšŸ“ NJšŸ“ 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

ā€¢ Assist and support regulatory CMC managers in the following activities:

ā€¢ Defining global CMC regulatory strategy and decisions for development projects or marketed products to achieve optimal submission/approval results and ensure regulatory compliance.

ā€¢ Communicating CMC regulatory strategy, key issues and remediation activities needed throughout the project/product life cycle, to project teams and appropriate management levels within and outside of Reg CMC.

ā€¢ Influencing and negotiating within cross-functional teams to ensure quality submission planning and decision-making.

ā€¢ Single point of contact with other line functions

ā€¢ Review CMC regulatory documentation to ensure strategic direction and regulatory compliance are met.

ā€¢ Collecting documentation from other line functions to support submission preparation

ā€¢ Ensure databases are maintained to compliance


Qualifications

Skills:

Desirable: Experience in regulatory field, in particular regulatory CMC


Education:Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent


Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.


Additional Information

Best Regards,

Anuj Mehta

973-967-3402

Frequently Asked Questions

Is the salary disclosed for the Regulatory CMC Associate Manager position at artechinformationsystemllc?
The salary for this Regulatory CMC Associate Manager 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 CMC Associate Manager position at artechinformationsystemllc located?
This Regulatory CMC Associate Manager role at artechinformationsystemllc is based in East Hanover, East Hanover, NJ, United States, NJ, 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 CMC Associate Manager role at artechinformationsystemllc full-time or part-time?
This is listed as a Contract position. It is posted as a Regulatory CMC Associate Manager role at artechinformationsystemllc.
How do I apply for the Regulatory CMC Associate Manager 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 CMC Associate Manager job at artechinformationsystemllc posted?
This Regulatory CMC Associate Manager position at artechinformationsystemllc was posted on Dec 2, 2015. Apply as soon as possible ā€” early applications are often reviewed first.
Regulatory CMC Associate Manager
artechinformationsystemllc
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