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Regulatory Affairs Associate II
Contract: North Chicago, Illinois, US
Salary Range: 45.00 - 52.00 | Per Hour
Job Code: 363452
End Date: 2025-08-10
Days Left: 5 days, 15 hours left
To discuss more about this job opportunity, please reach out to Himanshu Kumar Singh(LinkedIn URL - https://www.linkedin.com/in/himanshu-kumar-singh-57b782258/), email your updated resume at Email - himanshu.ksingh@collabera.com or give me a call at (425) 403-0902. Thank you!
Pay Rate: $45 - 52/hour
Position Details:
Industry: Pharmaceutical
Position Title: Regulatory Affairs Associate II
Duration: 12 months (Possible extensions)
Location: North Chicago, IL 60064 (Hybrid)
Job Description:
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices.
- May require an advanced degree and 3 to 5 years of direct experience in the field.
- Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- May lead and direct the work of others. A wide degree of creativity and latitude is expected.
What are the top 3-5 skills, experience or education required for this position:
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Familiar with pharmaceutical master batch records and how to author CMC submissions for clinical studies.
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Technical writing skills
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Familiar with typical manufacturing processes, especially cell cultures
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Familiar with microbial methodology
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Familiar with ICH and country regulatory procedures for clinical trials
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Able to work with electronic systems i.e., MS and dossier publication systems
Contractor requirements include:
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CMC (Chemistry, Manufacturing, Controls) background in completing clinical submissions
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IND/IMPD submission background based on manufacturing batch records
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Early Phase CMC knowledge a plus
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French/ English speaking a plus
Job Requirement
- CMC
- Regulatory
Reach Out to a Recruiter
- Recruiter
- Phone
- Himanshu Singh
- himanshu.ksingh@collabera.com
Apply Now
Apply Now
