Best Practices, Biology, Biotech and Pharmaceutical, Chemistry, Clinical Study Publications, Clinical Trial, Communication Skills, Cross-Functional, Detail Oriented, Document Management, Documentation, Drug Development, FDA (Food and Drug Administration), FDA Requirements, Information Technology & Information Systems, Investigational New Drug (IND), Manufacturing, Manufacturing Operations, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft PowerPoint, Microsoft Word, Multitasking, New Drug Application, Organizational Skills, Presentation/Verbal Skills, Process Improvement, Product Documentation, Product Lifecycle Management, Realtime Transport Protocol, Regulations, Regulatory Compliance, Regulatory Submissions, Small Molecules, Technical Operations, Writing Skills
Job Summary:
Piper Companies is seeking a Regulatory Affairs Specialist I - CMC to support our end client''s Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team. This position is onsite in Research Triangle Park (RTP), NC.
Responsibilities for the Regulatory Affairs Specialist I - CMC include:
- Author, review, and manage CMC regulatory documents and submission workflows.
- Support preparation and maintenance of regulatory submissions, including initial IND submissions for Phase I, II, and III clinical studies, New Drug Applications (NDAs), post-approval NDA supplements, CBE-30 supplements, and Annual Reports.
- Prepare, review, and maintain Module 3 (CMC) documentation for regulatory submissions.
- Coordinate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Technical Operations, and CMC subject matter experts to gather and review submission content.
- Ensure regulatory submissions are accurate, complete, and compliant with FDA regulations and internal timelines.
- Manage documentation and submission activities within Veeva RIM or a similar Regulatory Information Management system.
- Maintain regulatory documentation within electronic document management systems (EDMS).
- Support regulatory compliance initiatives and continuous process improvement activities.
Required Qualifications for the Regulatory Affairs Specialist I - CMC include:
- 2-3+ years of direct CMC Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Experience authoring and reviewing CMC regulatory documentation, including Module 3 content.
- Working knowledge of FDA regulatory submission requirements, including INDs, NDAs, post-approval supplements, and annual reports.
- Experience using Veeva RIM or a similar Regulatory Information Management system.
- Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, or a related scientific discipline preferred.
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook, and PowerPoint).
- Familiarity with electronic document management systems (EDMS) and regulatory publishing workflows.
- Strong organizational skills with exceptional attention to detail and the ability to manage multiple priorities in a fast-paced environment.
- Excellent written and verbal communication skills with the ability to work effectively on cross-functional teams.
Preferred Qualifications for the Regulatory Affairs Specialist I - CMC include:
- Experience supporting small-molecule pharmaceutical products.
- Experience supporting regulatory activities across multiple stages of development, from early-phase INDs through post-approval lifecycle management.
- Knowledge of FDA CMC regulations and global regulatory documentation best practices.
Compensation for the Regulatory Affairs Specialist I - CMC includes:
- Competitive hourly rate based on experience
- Comprehensive benefits package available to eligible consultants
This Job opens for applications on 6/26/2026. Applications for this job will be accepted for at least 30 days from the posting date.
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Keywords:
Regulatory Affairs Specialist, CMC Regulatory Affairs, Chemistry Manufacturing and Controls, Regulatory Submissions, IND Submissions, NDA Submissions, Module 3 Documentation, FDA Regulations, Veeva RIM, Regulatory Information Management, Regulatory Compliance, Pharmaceutical Regulatory Affairs, Biotechnology, Small Molecule Products, Regulatory Documentation, CBE-30 Supplements, NDA Supplements, Annual Reports, EDMS, Electronic Document Management Systems, Regulatory Publishing, Clinical Development, Product Lifecycle Management, RTP NC, Research Triangle Park, Pharmaceutical Development, FDA Submissions.