Global Regulatory Associate Director, Life Cycle Management

Novartis; Greater London; Hybrid; GBP 68,000 - 126,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Car allowance

Job summary

Novartis in London (The Westworks) seeks a Global Regulatory Associate Director to drive regulatory strategies across a complex portfolio and enable timely access to medicines worldwide.

You will collaborate cross-functionally, influence global health authority interactions, and shape lifecycle management while advancing your regulatory career in a collaborative, global environment. Hybrid remote options apply with on-site presence as needed.

Qualifications

• 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.

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.

Skills

Clinical Trials

Cross-Functional Teamwork

Detail-Oriented

Drug Development

Lifesciences

Problem Solving

Regulatory Compliance

Risk Management

Job description

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.

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 diverseteams’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:

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.

Skills Desired

Clinical Trials, Cross-Functional Teamwork, Detail-Oriented, Drug Development, Lifesciences (Inactive), Problem Solving Skills (Inactive), Regulatory Compliance, Risk Management