At a Glance
- Tasks: Shape the lifecycle of innovative medicines and drive regulatory strategies for global health.
- Company: Join Novartis, a leader in inclusive healthcare and innovation.
- Benefits: Competitive salary, flexible working options, and comprehensive benefits package.
- Other info: Diverse teams and a commitment to inclusion, with opportunities for mentorship and growth.
- Why this job: Make a real impact on patient outcomes while advancing your career in a collaborative environment.
- Qualifications: Bachelor's or Master's in a scientific field with regulatory experience in pharmaceuticals.
The predicted salary is between 67900 - 126100 £ per year.
This job is with Novartis, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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
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.
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?
Global Regulatory Associate Director, Life Cycle Management employer: Novartis
Novartis is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the dynamic environment of London. Employees benefit from hybrid working arrangements, allowing for flexibility while engaging in meaningful projects that enhance global security and resilience. With a strong focus on professional development and the application of cutting-edge AI technologies, Novartis provides ample opportunities for growth and impactful contributions to the healthcare sector.