Regulatory Manager, Life Cycle & CTA – Barcelona (Hybrid)

Novartis AG; Barcelona; Hybrid; EUR 46,000 - 86,000; Full time

Benefits offered by this job

Hybrid working options

14 weeks parental leave

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Job summary

Novartis is seeking a Regulatory Manager, Maintenance and CTA, to lead life cycle maintenance submissions from our Barcelona site. You will manage regulatory submissions and maintain compliance, coordinating with cross-functional teams to secure timely approvals.

This role requires strong regulatory expertise across major markets, fluency in Spanish, and experience with Health Authority interactions. The position offers hybrid work options and a comprehensive rewards package.

Qualifications

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

Responsibilities

• Deliver independently high-quality, compliant and timely life cycle management/maintenance submissions.
• Build strong regulatory knowledge across your 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.

Skills

Spanish fluency

Regulatory submissions

Regulatory planning

Cross-functional teamwork

Regulatory compliance

Experience with major markets

Safety/label interpretation

Education

Bachelor's or Master's in Science

Job description

Novartis is seeking a Regulatory Manager, Maintenance and CTA, to lead life cycle maintenance submissions from our Barcelona site. You will manage regulatory submissions and maintain compliance, coordinating with cross-functional teams to secure timely approvals.

This role requires strong regulatory expertise across major markets, fluency in Spanish, and experience with Health Authority interactions. The position offers hybrid work options and a comprehensive rewards package.