Associate Director, Regulatory Diagnostics

GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.; Greater London; Hybrid; GBP 68,000 - 126,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Minimum 14 weeks paid parental leave

Company vehicle or car allowance

Job summary

Novartis Pharmaceuticals UK Ltd. in London seeks an Regulatory Diagnostics Associate Director to shape global regulatory strategies for precision diagnostics, including companion diagnostics, and to support regulatory submissions across the product lifecycle.

You will collaborate with development teams and external partners to advance cutting-edge healthcare, driving impact in precision medicine within a highly collaborative environment.

Qualifications

• Experience in pharmaceutical industry with diagnostics focus.
• Contribution to regulatory projects for in vitro or companion diagnostics.
• Understanding of regulatory submission pathways (IDE, PMA, 510(k)).
• Experience with assay validation.

Responsibilities

• Design and deliver global regulatory strategies for precision diagnostics and companion diagnostics.
• 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 and briefing documents.
• Manage responses to regulatory requests and drive actions to resolution.
• Ensure compliance with global diagnostics regulations and support cross-functional training.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Communication skills

Negotiation skills

Problem solving

Lifesciences

Job description

Salary Range: £67,900.00 - £126,100.00

Job Description Summary

#LI-Remote (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).

#LI-Hybrid (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

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.

Job Description 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.

• insurance plans
• retirement plans
• wellbeing resources
• global recognition programs
• flexible and hybrid working options
• minimum 14 weeks paid parental leave
• company vehicle or a car allowance

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.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable.

A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Skills Desired

• Clinical Trials
• Cross-Functional Teams
• Detail-Oriented
• Drug Development
• Lifesciences
• Negotiation Skills
• Problem Solving Skills
• Regulatory Compliance
• Risk Management

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people's lives.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov.