Regulatory Affairs Specialist | $70/hr Remote

About the role

This is a remote contract position requiring 10-40 hours per week, with compensation ranging from $50 to $70 per hour.

Responsibilities

• Author and review evaluation tasks inspired by real-world agency requests and sponsor response threads.
• Apply expert judgment to review clinical documentation for regulatory compliance.
• Distinguish between substantively adequate and superficially polished responses.
• Assess consistency across comprehensive document sets, identifying unsupported or conflicting claims.
• Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines.
• Collaborate asynchronously and communicate complex regulatory concepts clearly.

Requirements

• Strong relevant experience in the domain of regulatory affairs.
• Documented experience drafting or leading responses to health authority information requests.
• Demonstrated working knowledge of the ICH framework and CTD/eCTD structure.
• Proven ability to critically read clinical or safety documents to identify regulatory risks.
• Exceptional written communication skills with the capability to convey regulatory reasoning clearly.
• Degree in life sciences, pharmacy, medicine, or a related field; RAC certification is an advantage.