At a Glance
- Tasks: Lead global regulatory strategies for innovative diagnostics and collaborate with diverse teams.
- Company: Join Novartis, a leader in transforming patient outcomes with a commitment to diversity.
- Benefits: Competitive salary, performance bonuses, flexible working, and extensive wellbeing resources.
- Other info: Hybrid working options available; join a community dedicated to innovation and collaboration.
- Why this job: Make a real impact in healthcare by shaping precision medicine and advancing diagnostics.
- Qualifications: Experience in pharmaceuticals with a focus on diagnostics and strong communication skills.
The predicted salary is between 67900 - 97000 £ per year.
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
Location: London (The Westworks), United Kingdom. Relocation Support: This role is based in London (The Westworks), United Kingdom. Novartis is unable to offer relocation support: please only apply if accessible.
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. This is an exciting opportunity for someone who is motivated by impact, thrives in complexity, and wants to play a visible role in advancing cutting-edge healthcare at a company committed to transforming patient outcomes.
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
At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen. Expected Annual Base Salary Range for role: £67,900-£97,000-£126,100. The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave. You may be eligible for a company vehicle or a car allowance in accordance with the applicable local Novartis policies and guidelines. 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, as outlined in our Code of Ethics.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives.
Associate Director, Regulatory Diagnostics employer: Novartis
At Novartis, we pride ourselves on being an inclusive employer that fosters a collaborative and forward-thinking work culture. As an Associate Director in Regulatory Diagnostics, you will have the opportunity to shape global regulatory strategies while enjoying competitive benefits, flexible working arrangements, and a commitment to employee growth and diversity. Join us in London to make a meaningful impact in advancing healthcare and transforming patient outcomes.
