Summary
For candidates based within a 50-mile radius of the office location, a hybrid working model applies, with an expectation of an on-site presence 12 days per month. Candidates residing more than 50 miles from the office may be considered for remote working arrangements, subject to role requirements and business needs. Location: London (The Westworks), United Kingdom. Novartis is unable to offer relocation support; please apply only if accessible.
About The Role
As Regulatory Diagnostics Associate Director, you will sit at the heart of precision medicine, helping to shape global regulatory strategies for innovative diagnostics, including companion diagnostics, that support more personalised treatment approaches for patients worldwide. In a highly collaborative, forward‑thinking environment, you will work across Regulatory Affairs, development teams and external partners to help bring scientific innovation to life.
Key Responsibilities
- Design and deliver global regulatory strategies for precision diagnostics, including companion diagnostics and in vitro devices.
- Lead and support regulatory submissions across lifecycle stages, including clinical studies and market authorisations.
- Integrate diagnostics regulatory strategy into early and late‑stage drug development programmes.
- Collaborate with global regulatory teams and country organisations to ensure compliant, timely submissions.
- Prepare and coordinate health authority interactions, including briefing documents and meeting participation.
- Manage responses to regulatory agency requests and drive follow‑up actions to resolution.
- Ensure compliance with global diagnostics regulations and support cross‑functional training and process implementation.
Essential 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.
Benefits & Rewards
Expected annual base salary range: £67,900-£97,000-£126,100. The base salary is determined based on gender‑neutral objectives and reviewed periodically. In addition to base salary, you may be eligible for a performance‑based bonus. Benefits include insurance plans, retirement plans, wellbeing resources, global recognition programmes, flexible and hybrid working options where possible, and a minimum of 14 weeks paid parental leave. You may be eligible for a company vehicle or a car allowance in accordance with local Novartis policies. Pay equity is a fundamental principle of our employment policy. Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
EEO & Diversity Commitment
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve. Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect.
