At a Glance
- Tasks: Shape the lifecycle of innovative medicines and drive regulatory strategies.
- Company: Join Novartis, a leader in healthcare innovation and patient impact.
- Benefits: Competitive salary, performance bonuses, flexible working, and generous parental leave.
- Other info: Inclusive culture with opportunities for mentorship and professional growth.
- Why this job: Make a real difference in patient outcomes while advancing your career globally.
- Qualifications: Degree in a scientific discipline and experience in regulatory processes.
The predicted salary is between 67900 - 126100 £ per year.
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. 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. Novartis is unable to offer relocation support: please apply only if accessible.
About The Role: 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
Expected Annual Base Salary Range for role: £67,900 to £126,100. In addition to your base salary, you may be eligible for a performance‑based bonus depending on certain performance parameters. The organization offers competitive benefits in kind to help you thrive personally and professionally, including insurance plans, retirement plans, wellbeing resources and global recognition programs. Flexible and hybrid working options are available where possible, and a minimum of 14 weeks paid parental leave is offered. The company vehicle or car allowance is available in accordance with local Novartis policies and guidelines.
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. 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. Collaborating, supporting and inspiring each other to achieve breakthroughs that change patients’ lives.
Global Regulatory Associate Director, Life Cycle Management in Cornwall employer: Novartis UK
Novartis is an exceptional employer, offering a dynamic and inclusive work environment in London that fosters collaboration and innovation. With a strong commitment to employee growth, competitive benefits, and flexible working arrangements, Novartis empowers its team to make a meaningful impact on patient outcomes while advancing their careers in the pharmaceutical industry.
