Date Posted: 08/01/2025
Hiring Organization: Rose International
Position Number: 486416
Industry: Healthcare
Job Title: Senior Regulatory Affairs Specialist CMC Small Molecules
Job Location: Deerfield, IL, USA, 60015
Work Model: Onsite
Shift: 8 to 5
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 10
Min Hourly Rate($): 45.00
Max Hourly Rate($): 48.00
Must Have Skills/Attributes: Documentation, Regulatory Affairs, SOP
Experience Desired: Understanding of applicable regulations and compliance requirements. (5 yrs); Word processing, spreadsheets, databases, and online research tools. (5 yrs)
Required Minimum Education: Bachelor’s Degree
Job Description
Required Education
• Bachelor’s degree in a scientific discipline.
• Minimum 5 years of regulatory or equivalent experience in pharmaceuticals/CROs, preferably with Small Molecule marketed products.
Required Skills:
• Expertise in US FDA/ICH guidelines and eCTD submission formats.
• Proven experience in preparing Module 3 CMC documents for post-approval submissions.
• Detail-oriented, collaborative, and adaptable to evolving priorities.
• Proficiency in Microsoft Office; familiarity with Veeva RIM is a plus.
• Strong written and verbal communication skills in English.
The Regulatory Affairs (CMC) Specialist will support global regulatory activities, with a focus on the United States, for Vanfive's product portfolio. Key responsibilities include managing CMC (Chemistry, Manufacturing, and Controls) submissions, lifecycle management, and ensuring compliance with regulatory requirements. The ideal candidate will have a strong understanding of FDA/ICH guidelines, excellent organizational skills, and proactive problem-solving abilities.
Key Responsibilities:
• Author and compile CMC sections (Module 3) for post-approval supplements/variations in eCTD format.
• Prepare and submit regulatory documents (e.g., Prior Approval Supplements, CBE, Annual Reports) to the FDA.
• Address regulatory agency inquiries related to CMC content.
• Maintain regulatory files in compliance with requirements.
• Develop and execute regulatory project plans for lifecycle management.
• Represent Regulatory Affairs in cross-functional team meetings.
• Support regulatory assessments for manufacturing changes and contribute to post-approval regulatory strategies.
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
Rose International maintained good communication during assignments and are very informative through email and phone calls.
Sade, Consultant
Rose International has been great to me. I thank everyone there for all of their hard work; it has not gone unnoticed.
Melody, Consultant
Your team at Rose International is always very helpful and responsive.
Barbara, Consultant
The interactions that I have had with your representatives have always been prompt and very professional. I am very pleased and impressed with your company and services.
Sioe, Consultant
Rose is an assembly of people grounded in honesty, truth and dignity for all of its employees and contractors.
Samba, Consultant
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