Regulatory Manager, Maintenance and CTA

About the role

Novartis is looking for a Regulatory Manager, Maintenance and CTA, based in Barcelona, Spain. The role manages regulatory activities for clinical trial applications across an assigned portfolio, working closely with study teams, country leads and cross-functional partners. It involves anticipating challenges, strengthening submissions and helping secure timely approvals, while contributing to continuous improvement across Regulatory Affairs. Relocation support is not offered.

Key responsibilities

• Lead high-quality clinical trial application submissions, aligned with regulatory requirements and internal processes.
• Build strong regulatory knowledge across the assigned product portfolio and relevant markets.
• Identify regulatory risks, gaps and trade-offs early to support timely submissions and approvals.
• Coordinate responses to Health Authority queries, developing robust justifications with regulatory and cross-functional partners.
• Maintain accurate product information within regulatory compliance and information management systems.
• Support preparation and finalisation of documentation for Health Authority interactions.
• Contribute to continuous improvement, simplification and automation initiatives across Regulatory Affairs.

Required profile

• Bachelor's or master's degree in a science-related discipline, with relevant regulatory experience.
• At least four years of knowledge and experience of regulations, guidelines and regulatory processes for clinical trial activities.
• Experience with regulatory submission and approval processes across major countries.
• Ability to understand and interpret safety and efficacy data and product labelling.
• Experience working in global, cross-functional or matrix teams in the pharmaceutical industry.

Required skills

• Planning, execution, regulatory review, compliance, reporting and submission activities.
• Strong regulatory knowledge of clinical trial regulations and guidelines.

What we offer

• Expected annual base salary range of EUR 46,300 to EUR 86,100, with a possible performance-based bonus.
• Flexible and hybrid working options, where possible.
• Minimum 14 weeks of paid parental leave.
• Insurance plans, retirement plans, wellbeing resources and global recognition programs.