Regulatory Manager, Clinical Trials — Hybrid (Barcelona)

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.; Sabadell; Híbrido; EUR 46.000 - 86.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid work options

14 weeks parental leave

Descripción de la vacante

Novartis is seeking a Regulatory Manager, Maintenance and CTA in Barcelona, Spain, to lead regulatory submissions for clinical trials across a portfolio. You will coordinate with global teams to ensure compliant documentation and timely approvals while driving continuous improvement within Regulatory Affairs.

The role requires a science degree with 4+ years in regulatory processes, strong planning and communication skills, and experience working in cross-functional or matrix teams in pharma.

Formación

• Bachelor’s or master’s degree in a science-related discipline, with 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.

Responsabilidades

• 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.

Conocimientos

Regulatory submissions

Regulatory guidelines

Cross-functional work

Global teams experience

Educación

Science degree

Descripción del empleo

Novartis is seeking a Regulatory Manager, Maintenance and CTA in Barcelona, Spain, to lead regulatory submissions for clinical trials across a portfolio. You will coordinate with global teams to ensure compliant documentation and timely approvals while driving continuous improvement within Regulatory Affairs.

The role requires a science degree with 4+ years in regulatory processes, strong planning and communication skills, and experience working in cross-functional or matrix teams in pharma.