Freelance Labeling Specialist

Global Regulatory Strategy | Clinical | Quality Executive | Proud Purdue mom

Company Description

Preferred Regulatory Consulting offers regulatory, quality, and clinical services to medical device and pharmaceutical companies across various development stages. We specialize in products spanning all three medical device classes, including software, active implantable devices, combination products, pharmaceutical products, and gene therapies. With expertise in areas such as cardiovascular, respiratory, neurology, orthopedics, and more, we deliver tailored support to our clients. Our consultancy has successfully secured significant regulatory designations, including orphan, fast track, breakthrough therapy, and rare pediatric disease designations from the FDA.

Role Description

This is a contract position for a remote Freelance Ad/Promo/Labeling Specialist. The Labeling Specialist will be responsible for developing, reviewing, and revising clients’ ad/promo/labeling materials for drugs in compliance with regulatory and market guidelines. The role involves ensuring accuracy and alignment with applicable regulations, managing labeling processes, and collaborating with cross‑functional teams. Attention to detail, adherence to deadlines, and clear communication is essential.

Experience negotiating labeling claims is a must.

Qualifications

• Proficiency in regulatory labeling requirements, and compliance processes
• Strong skills in documentation review and revision, ensuring accuracy and regulatory alignment in labeling
• Experience in pharmaceuticals, or biologics
• Detail‑oriented with excellent organizational, communication, and collaboration skills
• Ability to work independently and manage multiple deadlines in a fast‑paced environment
• Familiarity with FDA and EMA regulatory standards
• Masters degre in Life Sciences, or Regulatory Affairs is preferred

Entry level

Contract

Business Consulting and Services