Regulatory Lifecycle Manager (Hybrid – Barcelona)

(FCRS = US014) Novartis Pharmaceuticals Corporation; Barcelona; Hybrid; EUR 36,000 - 67,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Job summary

Novartis Pharmaceuticals Corporation in Barcelona, Spain, is seeking a Regulatory Associate Manager, Maintenance and CTA. The role focuses on delivering lifecycle management submissions and maintaining regulatory compliance across an assigned portfolio.

You will work with regulatory leads and cross-functional teams to manage submissions, health authority interactions, and timely approvals. Fluent English and Spanish are required, with a degree in a scientific or healthcare discipline.

Qualifications

• Fluent English and Spanish with strong written and verbal skills.
• Degree in a scientific or healthcare discipline, or equivalent pharmaceutical expertise.
• Strong knowledge of regulatory requirements and lifecycle management processes.

Responsibilities

• Deliver high-quality lifecycle management submissions in line with regulatory requirements.
• Build product and local regulatory knowledge to support portfolio activities.
• Identify regulatory risks and trade-offs to minimise delays and enable timely approvals.
• Coordinate responses to health authority queries with clear regulatory justifications.
• Maintain accurate product information in regulatory databases and management systems.
• Support preparation and finalisation of health authority documentation.
• Contribute to continuous improvement and automation initiatives in Regulatory Affairs.

Skills

Regulatory knowledge

Cross-functional communication

English and Spanish fluency

Planning & organisation

Education

Degree in scientific or healthcare discipline

Job description

Novartis Pharmaceuticals Corporation in Barcelona, Spain, is seeking a Regulatory Associate Manager, Maintenance and CTA. The role focuses on delivering lifecycle management submissions and maintaining regulatory compliance across an assigned portfolio.

You will work with regulatory leads and cross-functional teams to manage submissions, health authority interactions, and timely approvals. Fluent English and Spanish are required, with a degree in a scientific or healthcare discipline.