At a Glance
- Tasks: Design global regulatory strategies for precision diagnostics and lead submissions.
- Company: Join Novartis, a leader in innovative healthcare solutions.
- Benefits: Competitive salary, performance bonuses, flexible working, and generous parental leave.
- Other info: Dynamic work environment with a commitment to diversity and inclusion.
- Why this job: Make a real impact in the diagnostics field while collaborating with global teams.
- Qualifications: Experience in pharmaceuticals with a focus on diagnostics and strong communication skills.
The predicted salary is between 67900 - 97000 £ per year.
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.
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 for role: £67,900-£97,000-£126,100.
- In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.
- 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.
- Flexible and hybrid working options are available where possible, with minimum 14 weeks paid parental leave.
- You may be eligible for a company vehicle or a car allowance in accordance with 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.
Associate Director, Regulatory Diagnostics employer: Novartis Farmacéutica
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration 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 support work-life balance. Join us to be part of a diverse team dedicated to making a meaningful impact in the field of regulatory diagnostics, where your contributions will be valued and recognised.
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We think this is how you could land Associate Director, Regulatory Diagnostics
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We think you need these skills to ace Associate Director, Regulatory Diagnostics
Some tips for your application 🫡
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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 Novartis Farmacéutica that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Novartis Farmacéutica
✨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 Novartis Farmacéutica that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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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.
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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.
