Regulatory Affairs Specialist at micro1

Regulatory Affairs Specialist | $50–70/hr | Worldwide Remote

We are seeking an experienced Regulatory Affairs Specialist to support regulatory submissions and clinical documentation review within the medical domain. This is a fully remote contractor role ideal for a detail-oriented professional with a strong background in ICH guidelines and CTD/eCTD structure.

Key Responsibilities

• Prepare, review, and manage regulatory submissions in compliance with applicable guidelines
• Review and evaluate clinical documentation for accuracy, completeness, and regulatory compliance
• Apply ICH guidelines and CTD/eCTD formatting standards to submission packages
• Liaise with health authorities and support interactions throughout the review process
• Collaborate effectively with cross-functional remote teams to meet submission timelines
• Apply critical thinking to identify and resolve regulatory issues proactively

Required Skills & Experience

• Proven experience in regulatory affairs within the medical or pharmaceutical sector
• Strong knowledge of ICH guidelines and CTD/eCTD structure
• Experience with clinical documentation review and regulatory submissions
• Excellent written communication skills for preparing clear regulatory documents
• Strong attention to detail and critical thinking abilities
• Comfortable working in a fully remote, collaborative environment

This is a contractor engagement offering competitive hourly compensation between $50 and $70 per hour, depending on experience and qualifications.