Overview
In this role you help shape global regulatory strategies for precision diagnostics, including companion diagnostics and in vitro devices, to advance personalised treatment. You will work across Regulatory Affairs, development teams and external partners to bring scientific innovation to life. You’ll lead submissions across product lifecycles and integrate regulatory plans into development programmes, ensuring timely, compliant actions. This position offers visibility in a collaborative, forward‑looking environment with meaningful impact on patient outcomes. You will engage with health authorities and cross‑functional teams to drive strategic regulatory decisions in a rapidly evolving field.
Pay / Benefits
- hybrid working options
- 14 weeks paid parental leave
- insurance plans
- retirement plans
- car allowance or company vehicle
- global recognition programs
Responsibilities
- Design and deliver global regulatory strategies for diagnostics, including companion diagnostics and in vitro devices
- Lead and support regulatory submissions across lifecycle stages
- Integrate diagnostics regulatory strategy into early and late-stage drug development programmes
- Collaborate with global regulatory teams and country organisations for compliant submissions
- Prepare and coordinate health authority interactions, including briefing documents
- Manage responses to regulatory agency requests and follow-up actions
- Ensure compliance with global diagnostics regulations and support cross-functional training and process implementation
Key requirements
- Experience in the pharmaceutical industry with relevant diagnostics or in vitro diagnostics focus
- Demonstrated contribution to regulatory projects for in vitro diagnostics or companion diagnostics
- Experience within the diagnostics, in vitro diagnostics or companion diagnostics environment
- Understanding of regulatory submission pathways including Investigational Device Exemption, Premarket Approval and 510(k)
- Understanding of assay validation
- Strong interpersonal, communication and negotiation skills
- Interpersonal skills
- Negotiation skills
- Problem solving
- Regulatory Compliance
- Risk Management
- Regulatory submissions
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