Regulatory Team Lead, Maintenance and CTA

Novartis AG

Sabadell

Hybrid

EUR 64,000 - 118,000

Full time

2 days ago
Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Insurance plans
Retirement plans
Wellbeing resources
Global recognition programs
Hybrid working options
Parental leave

Job summary

Novartis in Barcelona is seeking a Regulatory Team Lead, Maintenance and CTA, to guide a global regulatory team responsible for delivering high-quality clinical trial submissions and approvals. You will combine people leadership with regulatory expertise, building partnerships across the organization while driving smarter ways of working through simplification and automation.

This role offers the chance to influence processes, develop talent, and contribute to an agile, future-ready Regulatory

Qualifications

  • 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 clinical trial 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.

Responsibilities

  • Lead and develop a global regulatory team delivering high-quality, compliant and timely clinical trial submissions and approvals.
  • 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.
  • 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.

Skills

Regulatory leadership
Global regulations
Regulatory submissions
Strategic planning
Process improvement
Cross-functional collaboration

Education

Bachelor's or Master’s degree in science

Job description

Salary Range:

€63,600.00 - €118,000.00

Job Description Summary

#LI-Hybrid

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.

Shape how global clinical trials move forward. As Regulatory Team Lead, Maintenance and CTA, you'll lead and develop a global regulatory team responsible for delivering high-quality, compliant and timely clinical trial submissions and approvals. 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.

Job Description
Key Responsibilities
  • Lead and develop a global regulatory team delivering high-quality, compliant and timely clinical trial submissions and approvals.
  • 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.
  • 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
  • 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 clinical trial 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.
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.

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Regulatory Manager, Maintenance and CTA
Regulatory Manager, Maintenance and CTA

Novartis AG • Sabadell

Hybrid
EUR 46,000 - 86,000
Hybrid work
Parental leave
Wellbeing programs
Regulatory Team Lead, Maintenance and CTA
Regulatory Team Lead, Maintenance and CTA

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. • Sabadell

Hybrid
EUR 64,000 - 118,000
Insurance plans
Retirement plans
Wellbeing resources
+2
Regulatory Manager, Maintenance and CTA
Regulatory Manager, Maintenance and CTA

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. • Sabadell

Hybrid
EUR 46,000 - 86,000
Insurance plans
Retirement plans
Wellbeing resources
+3
Senior Study Leader
Senior Study Leader

Novartis • Barcelona

Hybrid
EUR 64,000 - 118,000
Senior Study Leader
Senior Study Leader

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. • Sabadell

Hybrid
EUR 64,000 - 118,000
Insurance plans
Retirement plans
Wellbeing resources
+2
Technology Business Partner Development – Regulatory Affairs
Technology Business Partner Development – Regulatory Affairs

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. • Sabadell

Hybrid
EUR 65,000 - 121,000
Hybrid work options
Insurance plans
Retirement plans
+3
Senior Study Leader
Senior Study Leader

(FCRS = US014) Novartis Pharmaceuticals Corporation • Barcelona

Hybrid
EUR 64,000 - 118,000
Insurance plans
Retirement plans
Wellbeing resources
+3
Submission Readiness Document Manager
Submission Readiness Document Manager

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A. • Barcelona

Hybrid
EUR 46,000 - 86,000
Hybrid working options
Insurance plans
Retirement plans
+2
Technology Business Partner Development – Regulatory Affairs
Technology Business Partner Development – Regulatory Affairs

(FCRS = US014) Novartis Pharmaceuticals Corporation • Barcelona

Hybrid
EUR 65,000 - 121,000
Insurance plans
Retirement plans
Wellbeing resources
+2
Head DDIT ISC Software Development Governance, Integrity & Secure Software Development Life Cycle (S
Head DDIT ISC Software Development Governance, Integrity & Secure Software Development Life Cycle (S

Novartis • Barcelona

Hybrid
EUR 93,000 - 172,000
Insurance plans
Retirement plans
Wellbeing resources
+3