This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/11832340
Date Posted:04/15/2024
Hiring Organization:Rose International
Position Number:462267
Job Title:Regulatory Affairs Ops Specialist
Job Location:Round Lake, IL, USA, 60073
Work Model:Hybrid
Employment Type:Temporary
Estimated Duration (In months):13
Min Hourly Rate(\$):25.00
Max Hourly Rate(\$):28.00
Must Have Skills/Attributes:Communications, Regulatory Affairs,
Scheduling
**Only those lawfully authorized to work in the designated country
associated with the position will be considered.**
**Please note that all Position start dates and duration are
estimates and may be reduced or lengthened based upon a clients business
needs and requirements.**
\
Managing the preparation of regulatory submissions for IND, ANDA, NDA,
510K, AdProm, and other electronic submission types\
Creating timelines for regulatory filings\
Providing and maintain templates for authoring.\
Overseeing authoring and reviewing of regulatory documents\
QC submission documents\
Contribute to the development of process improvements and procedural
documents.\
Identifying and assessing regulatory risks and risks to timelines.\
Providing regulatory updates to the project team on different
milestones.\
Working cross functionally with project management, operations, IT and
other functions.\
Coordinate submission scheduling with regulatory publishing and ensures
delivery of high-quality documents.\
Working closely with other members of the Regulatory team and provide
support to their projects as needed.\
Maintaining archival of submissions and health authority communications
in Veeva RIM system.\
Provide regulatory representation on key meetings, including meetings
with health agency.\
\
What do you bring:\
Solid understanding and experience and interpretation of regulatory
requirements, with particular emphasis on the US region.\
Strong organization skills and the ability to track multiple timelines
in parallel and manage deadlines.\
Excellent written and verbal communication and ability to collaborate
across functions.\
Experience with Veeva Vault systems is preferred.\
Strong team player, self-motivated and able to function independently as
well as part of a team\
Able to work on multiple projects concurrently and adapt to a
continuously changing environment.\
BA/BS in a scientific field and 2-4 years of proven experience
Benefits:\
For information and details on employment benefits offered with this
position, please
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our HR Department via our
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California Pay Equity:\
For information and details on pay equity laws in California, please
visit the State of California Department of Industrial Relations\'
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Rose International is an Equal Opportunity Employer. All qualified
applicants will receive consideration for employment without regard to
race, color, religion, age, sex, sexual orientation, gender (expression
or identity), national origin, arrest and conviction records,
disability, veteran status or any other characteristic protected by law.
Positions located in San Francisco and Los Angeles, California will be
administered in accordance with their respective Fair Chance
Ordinances.
If you need assistance in completing this application, or during any
phase of the application, interview, hiring, or employment process,
whether due to a disability or otherwise,ple se contact our HR
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rel="noopener"}.
Rose International has an official agreement (ID #132522), effective
June 30, 2008, with the U.S. Department of Homeland Security, U.S.
Citizenship and Immigration Services, Employment Verification Program
(E-Verify). (Posting required by OCGA 13/10-91.).