Regulatory Affairs Engineer

Chicago, IL 60640

Employment Type: Contract Job Category: Quality Engineering Job Number: 53430693 Compensation: $60-100 / hour

Job Description

About the Company
Work with a global leader in drug delivery and combination products, delivering solutions that improve patient lives. Join a collaborative, innovative team with opportunities to grow and make an impact in international markets.

Position Details
  • Contract / Part-Time
  • 5–10 hours/week
  • 100% Remote
  • Pay: Open, based on experience
What You’ll Do
  • Develop and execute CMC strategies for combination products
  • Assess PK/PD impact and support device bridging (e.g., vial → autoinjector)
  • Author and review CTD Module 3 and device technical documentation
  • Prepare submissions for IND, BLA, NDA, and other global applications
  • Respond to Health Authority inquiries on CMC and drug-device compatibility
  • Track documents and coordinate with internal teams to meet deadlines
  • Support global submissions (EU, APAC, LATAM)
  • Contribute to risk assessments and mitigation strategies
What You’ll Need
  • Bachelor’s degree in a scientific discipline
  • 3–5 years Regulatory Affairs experience (pharma, biotech, or combination products)
  • Experience authoring and managing regulatory submissions
  • Strong understanding of CMC requirements for drugs/biologics
  • Knowledge of PK/PD concepts
  • Exposure to international regulatory frameworks
Nice to Have
  • Familiarity with medical device standards (ISO 13485, ISO 14971)
  • Experience with Design Control documentation (DHF, RMF)
Why You’ll Love It
  • Work on innovative combination products impacting patients globally
  • Join a collaborative, cross-functional team
  • Contribute to cutting-edge regulatory strategies
  • Grow your career with international exposure

Meet Your Recruiter

Tami Van

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information. 

 As one of the most respected names in engineering staffing, Sterling has hundreds of opportunities with top employers. If you’ve got a friend or colleague seeking their next move in engineering, we could have their next opportunity. We offer a referral bonus for every referral that we place. Submit referral now. 

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About Chicago, IL

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