Salary Range:
67900.00 - 126100.00Job 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).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 were committed to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role:67900-
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 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.
Read our brochure to learn more about our global total rewards offering:
Commitment to Diversity and Inclusion / EEO paragraph
Novartis is committed to building an outstanding inclusive work environment and diverseteamsrepresentative 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 ManagementRequired Experience:
Director
Associate Director, Regulatory Diagnostics • London, England, UK
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