Regulatory Associate Manager, Maintenance and CTA

Location: Barcelona Gran Vía, Spain

Salary Range

€36,100.00 - €67,100.00

Job Description Summary

#LI-Hybrid

Location: Barcelona, Spain

Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support: please only apply if accessible.

Make an impact where science, strategy and execution come together. As Regulatory Associate Manager, Maintenance and CTA, you’ll help deliver high-quality regulatory activities across an assigned portfolio, supporting lifecycle management activities through to timely submission and approval. Working closely with regulatory leads and cross-functional teams, you’ll apply your regulatory knowledge to identify challenges, support health authority interactions and keep critical activities moving forward. You’ll also have the opportunity to contribute to continuous improvement and automation initiatives, helping us work smarter while delivering for patients.

Key Responsibilities

• Deliver high-quality lifecycle management submissions in line with regulatory requirements.
• Build strong product and local regulatory knowledge to support assigned portfolio activities.
• Identify regulatory risks, gaps and trade-offs, helping minimise delays and enable timely approvals.
• Coordinate timely responses to health authority queries, supporting clear and robust regulatory justifications.
• Maintain accurate product information within regulatory compliance databases 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.