Regulatory Manager, Maintenance and CTA

Salary Range:

€46,300.00 - €86,100.00

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.

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 regulatory activities for clinical trial applications across an assigned portfolio, working closely with study teams, country leads and cross-functional partners. You’ll use your regulatory expertise to anticipate challenges, strengthen submissions and help secure timely approvals, while contributing to continuous improvement across Regulatory Affairs.

Job Description

Key Responsibilities

• •Lead high-quality clinical trial application submissions, ensuring alignment with regulatory requirements and internal processes.
• •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

• •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.

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.

Skills Desired