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About the role
Bring your medicine experience to this Regulatory Affairs Specialist opportunity.
Skills and focus areas
regulatory affairs · clinical documentation review · ich guidelines · ctd/ectd structure · written communication · critical thinking · regulatory submissions · health authority interactions · attention to detail · remote collaboration
What you will do
- Construct realistic assessment problems grounded in professional practice.
- Build or assess financial analyses, checking assumptions and the business implications.
- Check technical or professional work against the relevant compliance constraints.
- Apply clinical judgment to cases, documentation or model responses and explain the evidence.
Experience and requirements
- Relevant areas of expertise: regulatory affairs, clinical documentation review, ich guidelines, ctd/ectd structure.
- The client specifies: “5+ years of direct regulatory affairs experience at a sponsor, CRO, or consultancy, with responsibility for clinical submissions.”
Working arrangements
- The engagement is offered on a contractor basis.
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