Regulatory Team Lead, Maintenance and CTA

Novartis AG; Barcelona; On-site; EUR 64,000 - 118,000; Full time

Job summary

Novartis AG in Barcelona is seeking a Regulatory Team Lead, Maintenance and CTA to lead and develop a global regulatory team delivering high-quality, compliant and timely regulatory submissions for life cycle management and clinical trial applications.

You will combine people leadership with regulatory expertise, building partnerships across the organisation while driving smarter ways of working through simplification, continuous improvement and automation.

Qualifications

• Bachelor’s or Master’s degree in a science-related discipline with regulatory experience.
• Substantial knowledge of global regulations and processes supporting regulatory submissions.
• Experience leading regulatory professionals with people management skills.
• Strong communication and problem-solving abilities in cross-functional environments.
• Fluency in Spanish; Portuguese language skills are desirable.

Responsibilities

• Lead and develop a global regulatory team delivering high-quality, compliant life cycle management submissions.
• Coach and support team members, building capability and enabling growth.
• Allocate resources effectively across the assigned portfolio, balancing priorities and business needs.
• Drive process improvement, simplification and automation to strengthen operational excellence.
• Develop assigned country/regional regulatory knowledge.
• Build strong, customer-focused relationships with stakeholders and act on feedback.
• Foster collaboration and knowledge sharing across Regulatory Affairs and global teams.
• Champion change and role-model Novartis culture, values and behaviours.

Skills

Spanish fluency

People leadership

Regulatory submissions

Strategic planning

Cross-functional collaboration

Communication

Education

Bachelor’s or Master’s degree 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.

As Regulatory Team Lead, Maintenance and CTA, you’ll lead and develop a global regulatory team responsible for delivering high-quality, compliant and timely regulatory submissions and approvals for life cycle management and clinical trial applications. You’ll combine people leadership with regulatory expertise, building strong partnerships across the organisation while driving smarter ways of working through simplification, continuous improvement and automation. It’s an opportunity to develop talent, influence how we work and help build a more agile, future-ready Regulatory Affairs organisation.

About The Role

Key Responsibilities

• Lead and develop a global regulatory team delivering high-quality, compliant and timely life cycle management/maintenance submissions.
• Coach and support team members, building capability and enabling professional growth.
• Allocate resources effectively across the assigned portfolio, balancing priorities and business needs.
• Drive process improvement, simplification and automation to strengthen operational excellence.
• Develop assigned country / regional regulatory knowledge.
• Build strong, customer-focused relationships with key stakeholders and act on feedback.
• Foster collaboration and knowledge sharing across Regulatory Affairs and global teams.
• Champion change and role-model Novartis culture, values and behaviours.

Essential Requirements

• Fluency in Spanish.
• Bachelor’s or Master’s degree in a science-related discipline, with relevant regulatory experience and demonstrated capability.
• Substantial knowledge and experience of global regulations, guidelines and processes supporting regulatory submission activities.
• Demonstrated experience leading regulatory professionals, with strong people management, coaching and development capabilities.
• Strong experience in strategic planning, regulatory review, compliance, submissions and execution.
• Demonstrated ability to drive process improvement, simplification, automation and operational excellence.
• Strong communication, influencing and problem-solving skills within complex, cross-functional and international environments.

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: €63,600 to €118,000

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:

Learn about all the ways we’ll help you thrive personally and professionally.

Read our handbook (PDF 30 MB)