Join a cutting-edge biopharma team at a leading North Chicago, IL site known for its innovative approach to global manufacturing expansion. This role offers the opportunity to contribute directly to high-impact regulatory submissions supporting a new clinical manufacturing site in France. You'll play a key role in authoring Chemistry, Manufacturing, and Controls (CMC) content, using your technical writing and regulatory knowledge to support global clinical trial applications.
Ideal for someone with hands-on experience in pharmaceutical batch records, biologics manufacturing processes (especially cell culture), and a solid understanding of regulatory frameworks like ICH and FDA PMA guidance, this position allows you to work in a hybrid setup-with preference for onsite presence to stay closely connected to the fast-paced team environment.
location: North Chicago, Illinois
job type: Contract
salary: $40 - 50 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Author and compile CMC (Chemistry, Manufacturing, and Controls) content for regulatory submissions related to clinical studies
- Support regulatory filings for a new clinical manufacturing site, including ND/IMPD submissions based on manufacturing batch records
- Collaborate with cross-functional teams to collect and interpret data from manufacturing, validation, and engineering reports
- Review and approve study protocols, validation documents, and manufacturing changes for Class III implantable medical devices
- Prepare and submit various types of PMA supplements, including 30-day Notices, Real-Time Reviews, and Annual Reports
- Ensure compliance with regulatory guidelines (FDA, ICH, CFR) for global clinical trial applications
- Utilize electronic systems for document management, submission preparation, and regulatory tracking
- Stay current on evolving regulatory requirements and support the development of regulatory strategy for early-phase products
- Communicate and coordinate with internal teams and external partners to facilitate timely and accurate submissions
qualifications:
Required Skills & Qualifications
- Experience authoring CMC (Chemistry, Manufacturing, and Controls) submissions for clinical studies
- Familiarity with pharmaceutical master batch records
- Strong technical writing skills
- Understanding of typical manufacturing processes, particularly cell culture
- Knowledge of microbial methodology
- Familiarity with ICH guidelines and country-specific regulatory procedures for clinical trials
- Proficiency with electronic systems such as Microsoft Office and dossier publication platforms
- Background in ND/IMPD submissions based on manufacturing batch records
- Experience supporting early-phase clinical submissions
- Knowledge of FDA PMA guidance documents and CFR regulations
- Recent experience with Class III implantable medical devices
- Proven track record of successful PMA supplement submissions (e.g., 30-day Notices, Real-Time Reviews, Annual Reports)
- Ability to review and approve manufacturing and validation documentation
- 3-5 years of direct experience in Regulatory Affairs or related field (may require an advanced degree)
- French/English bilingual ability
- Early-phase CMC regulatory strategy knowledge
- Experience working within global regulatory environments
skills: Project Management, CMC, Regulatory Affairs Operations, Submissions
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 HRsupport@randstadusa.com.
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.
