Job Description:
Are you a Senior Regulatory Affairs Associate or Manager
with drug experience?
Every day, Kelly Scientific Resources connects
scientific professionals with opportunities to advance
their careers, and we currently have an opening for a
Regulatory Affairs Senior Associate.
This position is a long term contract, potential
Temp-to-Hire opportunity.
Primary Function:
The Associate will be responsible for executing
proactive gap assessment remediation activities in
accordance with project milestones.
Major Responsibilities:
With oversight, executes gap assessment remediation
activities as assigned.
Seeks expert advice and technical support as required to
accomplish resolution. Ensures accuracy and completeness
of all information.
Identifies regulatory activity and interacts with cross
functional team to execute action items.
Communicates status of remediation and issues on a
timely basis.
Revise regulatory submission files and other regulatory
documents as required.
Review regulatory application history to facilitate
remediation, as needed.
Skills:
Good communication and interpersonal skills.
Strong time management and prioritization.
Evaluates regulatory information to accurately and
efficiently maintain registrations and make improvements
as necessary, with oversight.
Developing problem solving skills.
Accountability:
Accountable for accuracy of work and meeting multiple,
simultaneous deadlines.
Responsible for effective cross-functional coordination
of remediation activities.
Accountable for effective communication of remediation
status including issues and modification to action
plans.
Looking for 3 yrs RA (pharmaceutical drug experience)
with BS (preferably in a technical area- chemistry,
biology, pharmacy) for senior associate.
***Please do not apply if you have focused on Clinical
Reg Affairs, publishing, or med device. Seeking Drug
pharmaceutical regulatory affairs experience only!
Apply now!!! Submit your resume and contact Kelly
Scientific Resources at (630) 705-0178 with questions.
Kelly Scientific Resources (KSR) is the leading
scientific and clinical research staffing company in the
world. We employ more than 700 clinical research
professionals and 4,500 scientists on an average workday
on a temporary, project and full-time basis in a broad
spectrum of industries and disciplines. KSR has more
than 100 locations in North America, Europe and the
Pacific Rim.
Please visit us at www.kellyscientific.com to learn
more.
Kelly Services is an Equal Opportunity Employer.
Job Code : BHJOB3479_384137
Kelly Scientific Resources - 9 months ago
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