Regulatory Affairs Specialist

micro1 is seeking a skilled Regulatory Affairs Specialist to contribute to an innovative project focused on AI development within the regulatory domain. In this role, you will leverage your deep industry expertise to train next-generation AI systems, ensuring that models learn to reason and perform based on high-quality, real-world regulatory inputs.

Key responsibilities

• Author and review evaluation tasks based on real-world agency requests, determining if drafted responses meet strict regulatory expectations.
• Apply expert judgment to clinical documentation, assessing whether conclusions are substantiated and records can withstand rigorous regulatory scrutiny.
• Distinguish between substantively adequate and superficially polished responses, providing clear rationales for any identified deficiencies.
• Assess consistency across comprehensive document sets to identify unsupported or conflicting claims.
• Provide structured, well-reasoned written feedback grounded in applicable regulatory guidelines.

Requirements

• 5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with a focus on clinical submissions.
• Documented experience drafting or leading responses to health authority information requests for ongoing regulatory filings.
• Working knowledge of the ICH framework, CTD/eCTD structure, and practical expectations of major regulatory bodies like the FDA or EMA.
• Proven ability to critically read clinical or safety documents to identify regulatory risks and potential reviewer concerns.
• Degree in life sciences, pharmacy, medicine, or a related field.

What we offer

• The opportunity to shape the future of AI in the regulatory affairs industry.
• A fully remote work environment allowing for asynchronous collaboration.
• Engagement in high-impact projects that leverage your specialized domain knowledge.