Senior Associate, Regulatory Affairs
Company: The Judge Group
Posted on: November 26, 2022
Location: Morristown, NJ Description: Our client is currently
seeking a Senior Associate, Regulatory Affairs This job will have
the following responsibilities:
- Oversee and manage assembly and publishing of all documents
while maintaining adherence to FDA standards and internal
- Interacts effectively with functional business units to
coordinate/facilitate procurement of documentation required for
submissions, ensuring that departmental timelines are met.
- Represents regulatory affairs in project team meetings and
provides regulatory guidance and perspective to team members in
determining appropriate actions in order to meet scheduling
timelines and/or in resolving technical issues.
- Reviews technical documents for accuracy and acceptability for
use in new ANDAs, NDAs, Amendments, Supplements, Annual Reports and
other required FDA filings to ensure high-quality submissions and
expeditious approvals from FDA.
- Independently authors, compiles, reviews and submit
high-quality, more complex, original new ANDAs, NDAs, Amendments,
Supplements and Annual Reports.
- Review Modules in eCTD and verify proper hypertext linking and
ensure navigational tools are functional
- Reviews and signs-off on change control documentation. Assesses
changes and their impact to the business based on an advanced
understanding of regulatory guidelines and applicable federal
- Assists in formulating sound strategies in support of
submission goals. Qualifications & Requirements:
- Minimum of a Bachelor's Degree in a life science. Advanced
- Minimum of 5 years in the pharmaceutical industry with 3-4 of
those years in regulatory affairs. Contact: This job and many more
are available through The Judge Group. Find us on the web at
Keywords: The Judge Group, Newark , Senior Associate, Regulatory Affairs, Other , Morristown, New Jersey
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