Regulatory Manager, Maintenance and CTA

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

Summary

Primary Location: Barcelona, Spain

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

Help shape the path from clinical development to patients by bringing regulatory precision to every submission. As Regulatory Manager, Maintenance and CTA, you’ll manage timely regulatory submissions and approvals for life cycle management and clinical trial applications. You’ll use your regulatory expertise to anticipate challenges, strengthen submissions and help secure timely approvals, while contributing to continuous improvement across Regulatory Affairs.

About The Role

Key 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.

Essential Requirements

• Fluency in Spanish.
• Bachelor’s or master’s degree in a science-related discipline, with relevant regulatory experience and demonstrated capability.
• 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.

Desirable Requirements

• Fluency in Portuguese.

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: €46,300 to €86,100

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:

https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards

Read our handbook (PDF 30 MB)