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    • Shape the lifecycle of innovative medicines and ensure patients continue to benefit long after approval.
    • Independently manage regulatory maintenance activities…
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    • Experience with Class III medical device regulatory affairs or equivalent compliance environment.
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    • Existing auditor experience on behalf of a Notified Body.
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    • Day off on your birthday.
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    • Prior experience supporting medical device submissions or regulatory inspections.
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    • Working knowledge of ISO 13485 (medical device quality management) and IEC 62304 (medical device software lifecycle).
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    • Knowledge of relevant regulatory frameworks and standards, including ISO 13485, IEC 62304, and Class III medical device regulations.
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    • Domain: Class III medical device · regulatory affairs.
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Global Regulatory Associate Director, Life Cycle Management
Novartis
·
4.1
London
•
Hybrid work
£67,900 - £126,100 a year
Full-time
Apply on company site

Job details

£67,900 - £126,100 a year
Full-time
Hybrid work in London

Full 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).

Primary 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.

Shape the lifecycle of innovative medicines and ensure patients continue to benefit long after approval. As a Global Regulatory Associate Director, you will play a critical role in driving high-quality regulatory strategies across a complex portfolio, influencing global health authority interactions and enabling timely access to treatments worldwide. This is an opportunity to combine deep regulatory expertise with cross-functional collaboration, making a tangible impact on patient outcomes while advancing your career in a collaborative, global environment.

About the Role

Key Responsibilities

  • Independently manage regulatory maintenance activities for assigned high-complexity product portfolio.
  • Ensure timely, compliant preparation and submission of regulatory maintenance deliverables.
  • Provide strategic regulatory input to cross-functional deliverables, including safety reports, variations, and renewals.
  • Act as a liaison with health authorities, supporting interactions for complex regulatory matters where required.
  • Identify risks, gaps, and trade-offs to support timely approvals and minimise regulatory delays.
  • Lead responses to health authority queries, including development of robust scientific justifications.
  • Contribute to continuous improvement initiatives and support mentorship or onboarding of junior associates.

Essential Requirements

  • Bachelor’s or Master’s degree in a scientific discipline, or equivalent experience.
  • Significant experience in regulatory maintenance activities and regulatory processes within the pharmaceutical industry.
  • Proven knowledge of global regulatory submission and approval processes across major regions.
  • Experience in planning, execution, regulatory review, and compliance of submissions.
  • Ability to interpret safety and efficacy data and product labelling requirements.
  • Strong communication skills with a proactive, accurate, and stakeholder-focused approach.
  • Demonstrated ability to work effectively in cross-functional, global matrix environments.
  • Experience contributing to process improvements, simplification, or operational excellence initiatives.

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 to £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.

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.

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.

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

Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)


Primary location salary range
£67,900.00 - £126,100.00
Division
Development
Business Unit
Development
Location
United Kingdom
Site
London (The Westworks)
Company / Legal Entity
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
Alternative Location 1
Home Worker, United Kingdom
Functional Area
Research & Development
Job Type
Full time
Employment Type
Regular
Shift Work
No

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