REGULATORY ASSOCIATE
Position Responsibilities:
This position is an entry level Regulatory Associate in the
Chemistry, Manufacturing and Controls (CMC) group.
Responsibilities include:
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Supporting the regulatory
managers in the day to day activities |
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Co-ordinate multiple
projects |
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Assemble and review
ANDA’s |
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Responsible for post-approval
ANDA life cycle |
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Interact with FDA Project
Managers on a regular basis to monitor the status of
applications and co-ordinate information to the product
related queries in a timely and efficient manner. |
Qualifications:
(Include special educational requirements and/or work experience,
skills and physical requirements).
Minimum of 1 year experience in the pharmaceutical industry.
Preferably in Regulatory Affairs. Must have knowledge of ANDA/NDA
submissions.
Know How:
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Time management
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Self starter, with
excellent organizational skills
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The ability to multi-task |
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To know who to direct
the appropriate questions to in order to facilitate
timely responses.
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Accountability:
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To understand the
implications of delays in submission of responses, supplements,
amendments, etc. to FDA
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To be able to identify
delays and inform the regulatory project manager to
facilitate a resolution
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Interested applicants should submit their
resume to Desiree Timmerman at desiree.timmerman@ranbaxy.com.
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