Global Regulatory Associate Director – Life Cycle Management

About the role

Novartis is seeking a Global Regulatory Associate Director to lead life‑cycle management for a high‑complexity product portfolio. You will ensure regulatory maintenance activities are executed on time, compliant and aligned with global strategies, while acting as a key liaison with health authorities.

Key responsibilities

• Independently manage regulatory maintenance activities for assigned high‑complexity products.
• Prepare and submit regulatory maintenance deliverables in a timely and compliant manner.
• Provide strategic regulatory input to cross‑functional deliverables such as safety reports, variations and renewals.
• Liaise with health authorities and support complex regulatory interactions.
• Identify risks, gaps and trade‑offs to support timely approvals and minimise delays.
• Lead responses to health authority queries, developing robust scientific justifications.
• Contribute to continuous‑improvement initiatives and mentor junior associates.

Required profile

• Bachelor’s or Master’s degree in a scientific discipline or equivalent experience.
• Significant experience in regulatory maintenance activities and 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 labeling requirements.
• Strong communication skills with a proactive, accurate, stakeholder‑focused approach.
• Demonstrated ability to work effectively in cross‑functional, global matrix environments.
• Experience contributing to process improvements, simplification or operational‑excellence initiatives.

Required skills

What we offer

• Competitive annual base salary range £67,900 – £126,100.
• Performance‑based bonus eligibility.
• Comprehensive benefits including insurance, retirement plans, wellbeing resources and global recognition programs.
• Flexible and hybrid working options.
• Minimum 14 weeks paid parental leave.
• Potential company vehicle or car allowance according to local policy.
• Commitment to diversity, inclusion and pay equity.