Regulatory Affairs Specialist, ICH & eCTD Compliance

You will own regulatory documentation review for AI-driven healthcare projects, evaluating clinical and regulatory submissions for compliance. You'll assess ICH guidelines and CTD/eCTD structures and deliver evidence-based feedback to refine AI-generated content. Part of a remote team, you'll collaborate with cross-functional stakeholders to mitigate regulatory risk. Unlike traditional roles, you'll shape AI outputs in a fast-evolving domain.

Own regulatory compliance for AI-driven healthcare projects at YO AI Labs, reviewing clinical and regulatory documentation for CTD/eCTD submissions. Partner with cross-functional teams to ensure ICH guideline adherence and mitigate regulatory risks. You will provide evidence-based feedback that directly shapes AI-generated content. This contract role offers remote flexibility and the chance to influence emerging health tech.

Own regulatory documentation review for AI-driven healthcare projects, ensuring clinical and regulatory submissions meet ICH and CTD/eCTD standards. Collaborate with cross-functional teams to validate AI-generated content, reducing compliance risk across global submissions. This remote contract role focuses on evidence-based feedback, not routine document processing.

You will author and review clinical and regulatory documents, including Clinical Study Reports (CSRs) and safety reports, ensuring scientific accuracy and compliance with ICH guidelines. You will work with cross-functional teams and support AI-assisted documentation evaluation. 5+ years of regulatory medical writing experience and strong knowledge of ICH E3, ICH E2F, and ICH E2C are essential. This role offers the chance to shape documentation quality in a remote, contract capacity.

You will own the full lifecycle of clinical and regulatory documents, from drafting Clinical Study Reports (CSRs) to final submission. You will interpret ICH E3 guidelines and verify scientific accuracy against source data and TFLs. You will collaborate with cross-functional teams to deliver compliant, high-quality documents. This role also supports AI-assisted documentation evaluation, combining writing expertise with modern tools. You will work remotely with flexible hours, focusing on oncology and haematology studies.

You will own global regulatory strategy and submissions for our oncology pipeline, driving INDs, NDAs, and BLAs through FDA and EMA approvals. Reporting to the VP of Regulatory Affairs, you will lead cross-functional teams across Clinical, CMC, and Pharmacovigilance to ensure compliance and speed. This role suits a hands-on strategist eager to shape regulatory precedent in a small, nimble biotech. You will directly influence agency interactions and regulatory policy, making a tangible impact on patient access.