Regulatory Affairs Specialist

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.