Regulatory Manager, Clinical Trials - Hybrid (Barcelona)

(FCRS = US014) Novartis Pharmaceuticals Corporation; Barcelona; Hybrid; EUR 46,000 - 86,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working options

14 weeks parental leave

Job summary

Novartis Pharmaceuticals Corporation in Barcelona, Spain, seeks a Regulatory Manager, Maintenance and CTA, to steer regulatory activities for clinical trial applications across an assigned portfolio. You will collaborate with study teams, country leads and cross-functional partners to strengthen submissions and drive timely approvals.

You’ll contribute to continuous improvement in Regulatory Affairs while supporting a hybrid work model in Barcelona.

Qualifications

• Bachelor’s or master’s degree in a science-related discipline with regulatory experience.
• At least four years’ knowledge and experience of regulations for clinical trial activities.
• Experience with regulatory submissions and approvals across major countries.
• Strong experience in planning, execution, regulatory review, compliance and reporting.

Responsibilities

• Lead high-quality regulatory submissions for clinical trial applications.
• Build regulatory knowledge across the product portfolio and markets.
• Identify regulatory risks and trade-offs early to support timely submissions and approvals.
• Coordinate responses to Health Authority queries with regulatory and cross-functional partners.
• Maintain accurate product information within regulatory systems.
• Support preparation and finalisation of documentation for Health Authority interactions.
• Contribute to continuous improvement across Regulatory Affairs.

Skills

Regulatory submissions

Regulatory processes

Cross-functional teams

Clinical trial knowledge

Education

Bachelor’s or Master’s degree in science

Job description

Novartis Pharmaceuticals Corporation in Barcelona, Spain, seeks a Regulatory Manager, Maintenance and CTA, to steer regulatory activities for clinical trial applications across an assigned portfolio. You will collaborate with study teams, country leads and cross-functional partners to strengthen submissions and drive timely approvals.

You’ll contribute to continuous improvement in Regulatory Affairs while supporting a hybrid work model in Barcelona.