
Job Information
Robert Half USA - Regulatory Affairs Associate III in Chapel Hill, North Carolina
Description We are seeking a Regulatory Affairs Associate III to join our team. This opportunity offers a long term contract employment with the possibility to work fully remotely or in hybrid mode from Chapel Hill, North Carolina. As a Regulatory Affairs Associate III, you will play a key role in coordinating and preparing regulatory submissions, reviewing technical data, and managing regulatory documentation.
Responsibilities:
• Coordinate the preparation of documents and packages for regulatory submissions
• Review and evaluate scientific data and reports to support product submissions
• Track the status and progress of all regulatory documentation
• Review, edit, and proofread regulatory documentation to ensure accuracy and consistency
• Assist in the preparation and review of product labeling, Standard Operating Procedures (SOPs), and other departmental documents
• Compile regulatory documents for submission under supervision
• Participate in project teams as needed, contributing a regulatory affairs perspective
• Respond to inquiries from regulatory authorities and prepare comprehensive responses
• Maintain regulatory files in a format consistent with regulatory requirements
• Stay updated with regulatory requirements to ensure compliance
• Manage a specific product portfolio in the region as required. Requirements • Proficiency in documentation and research, with the ability to effectively review and manage databases.
• Experience in supervising teams, ensuring adherence to regulations and tracking progress.
• Strong skills in using spreadsheets and other word processing tools.
• Excellent communication skills, both written and verbal.
• Familiarity with labeling and proofreading processes.
• Experience in coordinating and preparing responses for regulatory submissions.
• Knowledge of standard operation procedures and their implementation.
• Background in pharmacy or a healthcare environment would be beneficial.
• Experience in managing project teams and coordinating efforts towards common goals.
• Understanding of disability benefits and their regulatory requirements.
• Familiarity with Cedar.AI or similar regulatory affairs tools.
• Prior experience in regulatory affairs.
• Ability to prepare and manage regulatory documents.
• Ability to work in a fast-paced environment, meeting regulatory submissions deadlines.
• Must be eligible to work in the U.S. Innovation starts with people.®
Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more.
All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
© 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https://www.roberthalf.com/us/en/terms) .
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