At a Glance
- Tasks: Shape global regulatory strategies for innovative diagnostics in a collaborative environment.
- Company: Join Novartis, a leader in transforming patient outcomes through precision medicine.
- Benefits: Competitive salary, performance bonuses, flexible working, and comprehensive wellbeing resources.
- Other info: Diverse and inclusive workplace with excellent career growth opportunities.
- Why this job: Make a real impact in advancing cutting-edge healthcare and personalised treatment approaches.
- Qualifications: Experience in pharmaceuticals with a focus on diagnostics and strong communication skills.
The predicted salary is between 90000 - 126100 £ per year.
Salary Range: £67,900.00 - £126,100.00
#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.
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.
Commitment to Diversity and Inclusion / EEO
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
Associate Director, Regulatory Diagnostics in London employer: Healthcare Businesswomen’s Association
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic and collaborative work environment in the heart of London. Our commitment to employee growth is reflected in our comprehensive benefits package, including competitive salaries, performance-based bonuses, and flexible working arrangements that promote work-life balance. Join us to be part of a forward-thinking team dedicated to transforming patient outcomes through innovative diagnostics and personalised medicine.
Contact Details:
Healthcare Businesswomen’s Association Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Regulatory Diagnostics in London
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Healthcare Businesswomen’s Association. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Healthcare Businesswomen’s Association.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Healthcare Businesswomen’s Association. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Healthcare Businesswomen’s Association is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Associate Director, Regulatory Diagnostics in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Healthcare Businesswomen’s Association!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Healthcare Businesswomen’s Association that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Healthcare Businesswomen’s Association!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Healthcare Businesswomen’s Association, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Healthcare Businesswomen’s Association
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Healthcare Businesswomen’s Association that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Healthcare Businesswomen’s Association’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
