Head of Regulatory Operations at Novartis
london, London - England, United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

17 Dec, 26

Salary

55000.0

Posted On

18 Sep, 26

Experience

6 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Pharmaceutical Manufacturing

Description


Primary Location: London, United Kingdom

Other Locations: Remote, United Kingdom


Relocation Support: This role is based in London, United Kingdom. Novartis is unable to offer relocation support: please only apply if accessible.


Imagine leading the transformation of regulatory operations on a global scale, accelerating the delivery of life-changing medicines to patients around the world. As Head of Regulatory Operations, you will shape the future of regulatory excellence by driving enterprise-wide innovation across regulatory data, digital platforms, submissions, and operational execution. Leading a high-performing global organisation, you will champion cutting-edge technologies, including artificial intelligence and automation, to redefine how regulatory information is managed, submitted, and leveraged across the development portfolio. This is a rare opportunity to influence strategic decisions at the highest levels, build world-class capabilities, and create lasting impact on patient access, business performance, and the future of Novartis.

About the Role

Key Responsibilities

  • Define and deliver the global Regulatory Operations strategy to accelerate patient access to innovative medicines.
  • Lead regulatory submissions, publishing, data management, and operational excellence across the development portfolio.
  • Drive digital transformation through artificial intelligence, automation, and emerging technologies.
  • Build and sustain trusted regulatory data foundations, governance frameworks, and quality standards.
  • Partner with senior stakeholders to optimise processes, enhance performance, and deliver business value.
  • Lead, develop, and inspire a high-performing global team while fostering an inclusive culture.
  • Ensure compliant, high-quality regulatory submissions and effective engagement with Health Authorities worldwide.

Essential Requirements

  • Extensive pharmaceutical industry experience within global Regulatory Operations or closely related functions.
  • Proven success leading large, geographically dispersed teams and building high-performing organisations.
  • Deep expertise in global regulatory submissions and complex filing strategies across international markets.
  • Strong understanding of the end-to-end drug development lifecycle and portfolio management principles.
  • Exceptional communication, stakeholder engagement, negotiation, and executive influencing capabilities.
  • Demonstrated ability to drive innovation, digital transformation, and continuous operational improvement.

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: £104,790 to £194,610

  

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. 

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Long-term equity awards granted at group level may also be part of your package. Further details will be provided during the application process.  

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: 

  

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. 

Why Novartis: 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. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Responsibilities

Build our future together:

We're seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational science with diagnostic execution. This role owns CDx programs from early biomarker feasibility through clinical validation, regulatory submission, and launch translating biological insights and clinical hypotheses into validated, fit-for-purpose assays that support drug development decisions. You'll work at the interface of biomarker science, clinical development, regulatory, and external IVD partners to ensure diagnostics keep pace with therapeutic milestones.

When & where:

  • Location: Uxbridge, United Kingdom (multiple locations are being considered for this role.)
  • Work model/flexibility: 3 days onsite

Discover your role:

  • Translate emerging biomarker and mechanism-of-action data into diagnostic target product profiles (TPPs), defining assay intent across platforms (Next Generation Sequencing, polymerase chain reaction, immunohistochemistry, immunoassays).
  • Partner with translational and clinical teams to design biomarker strategies for patient selection, stratification, and enrichment, including sample strategy and specimen logistics.
  • Lead analytical and clinical validation planning (accuracy, precision, sensitivity/specificity, limit of detection, reproducibility), linking assay performance to clinical safety and efficacy endpoints.
  • Set global CDx strategy for assigned programs, aligning diagnostic milestones with clinical and regulatory timelines.
  • Select and oversee In Vitro Diagnostic (IVD) development partners; manage co-development scope, timelines, and quality expectations.
  • Support global regulatory strategy and submissions (Food and Drug Administration PMA/supplement, EU IVDR, PMDA) in collaboration with IVD Regulatory, including labeling alignment.
  • Ensure compliance with relevant standards (ISO 13485, ISO 14971, CLSI, IVDR, GCP alignment).
  • Lead cross-functional working groups, translating scientific rationale into program plans and clear governance reporting.
  • Support design transfer, manufacturing readiness, and launch preparation with commercial and medical affairs.

This role requires:

  • PhD or advanced degree in molecular biology, pathology, biomedical engineering, or related translational/biomedical science field.
  • 8+ years in diagnostics or translational research, with 4+ years leading biomarker-driven CDx or IVD programs bridging bench discovery and clinical application.
  • Track record translating biomarker science into validated assays supporting drug approvals.
  • Working knowledge of global CDx regulatory pathways (FDA CDRH, EU IVDR, PMDA).
  • Ability to translate complex scientific and clinical data for cross-functional and executive audiences.
  • Experience managing external partners and multi-workstream programs under QMS/GxP-adjacent conditions.

#PrecisionMedicineCDX


Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.


Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.


As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

Primary Location: London, United Kingdom

Other Locations: Remote, United Kingdom


Relocation Support: This role is based in London, United Kingdom. Novartis is unable to offer relocation support: please only apply if accessible.


Imagine leading the transformation of regulatory operations on a global scale, accelerating the delivery of life-changing medicines to patients around the world. As Head of Regulatory Operations, you will shape the future of regulatory excellence by driving enterprise-wide innovation across regulatory data, digital platforms, submissions, and operational execution. Leading a high-performing global organisation, you will champion cutting-edge technologies, including artificial intelligence and automation, to redefine how regulatory information is managed, submitted, and leveraged across the development portfolio. This is a rare opportunity to influence strategic decisions at the highest levels, build world-class capabilities, and create lasting impact on patient access, business performance, and the future of Novartis.

About the Role

Key Responsibilities

  • Define and deliver the global Regulatory Operations strategy to accelerate patient access to innovative medicines.
  • Lead regulatory submissions, publishing, data management, and operational excellence across the development portfolio.
  • Drive digital transformation through artificial intelligence, automation, and emerging technologies.
  • Build and sustain trusted regulatory data foundations, governance frameworks, and quality standards.
  • Partner with senior stakeholders to optimise processes, enhance performance, and deliver business value.
  • Lead, develop, and inspire a high-performing global team while fostering an inclusive culture.
  • Ensure compliant, high-quality regulatory submissions and effective engagement with Health Authorities worldwide.

Essential Requirements

  • Extensive pharmaceutical industry experience within global Regulatory Operations or closely related functions.
  • Proven success leading large, geographically dispersed teams and building high-performing organisations.
  • Deep expertise in global regulatory submissions and complex filing strategies across international markets.
  • Strong understanding of the end-to-end drug development lifecycle and portfolio management principles.
  • Exceptional communication, stakeholder engagement, negotiation, and executive influencing capabilities.
  • Demonstrated ability to drive innovation, digital transformation, and continuous operational improvement.

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: £104,790 to £194,610

  

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. 

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Long-term equity awards granted at group level may also be part of your package. Further details will be provided during the application process.  

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: 

  

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. 

Why Novartis: 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. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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