Regulatory Affairs Associate I
Ready to elevate your regulatory career? This opportunity allows you to take ownership of managing, compiling, and authoring CMC sections for marketed product variations, directly influencing global compliance and product lifecycles. Based out of a state-of-the-art facility in Lake County, this role offers a dynamic hybrid schedule balancing collaborative on-site teamwork with remote flexibility. location: North Chicago, Illinois
job type: Contract
salary: $29.00 - 32.29 per hour
work hours: 9 to 5
education: Bachelors responsibilities:
- Manage, compile, and author CMC sections and CTD content for marketed product variations.
- Partner with RA CMC Project Leads to develop Module 3 content and project timelines.
- Independently facilitate project team meetings and run review meetings for submission documents.
- Author and submit PMA supplements, including 30-day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
- Review and approve manufacturing changes, engineering study protocols, and validation reports for Class III implantable medical devices.
- Coordinate cross-functional activities with global personnel to ensure the file-ability and accuracy of regulatory dossiers.
qualifications:
Required Skills
- Degree: BA/BS in Chemical, Biological Sciences, or a relevant discipline.
- Experience: 1-2 years of pharmaceutical industry experience and 1-2 years of cross-functional project management.
- Technical: Experience authoring/submitting Class III implantable PMA supplements; knowledge of FDA PMA guidance and CFR regulations.
- Systems: Proficiency with electronic document management systems.
- 1-2 years of experience specifically in Regulatory Affairs, R&D, or Manufacturing (focused on CTD Module 3).
- Familiarity with US and international regulatory dossier requirements.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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