Regulatory Manager, Clinical Trials Submissions – Hybrid

Novartis AG; Sabadell; Hybrid; EUR 46,000 - 86,000; Full time

Benefits offered by this job

Hybrid work

Parental leave

Wellbeing programs

Job summary

Novartis AG in Barcelona, Spain, seeks a Regulatory Manager, Maintenance and CTA, to lead regulatory submissions for clinical trial applications across an assigned portfolio, coordinating with study teams, country leads and cross-functional partners.

The role requires a science degree with 4+ years of regulatory experience, plus strong planning, submission, and labeling interpretation skills; Novartis emphasizes regulatory excellence, continuous improvement, and hybrid work options.

Qualifications

• Bachelor's or master's degree in a science-related field with regulatory experience.
• At least four years' regulatory experience with clinical trial activity.
• Experience with regulatory submission and approvals across major countries.
• Strong planning, execution, and submission capabilities.
• Ability to interpret safety and efficacy data and labeling.
• Experience in global cross-functional or matrix teams in pharma.

Responsibilities

• Lead high-quality regulatory submissions for clinical trials.
• Build regulatory knowledge across product portfolio and markets.
• Identify regulatory risks early to support timely submissions.
• Coordinate responses to Health Authority queries with cross-functional partners.
• Maintain product information in regulatory systems.
• Prepare and finalize documentation for Health Authority interactions.
• Support continuous improvement initiatives in Regulatory Affairs.

Skills

Regulatory affairs

Clinical trial submissions

Cross-functional collaboration

Regulatory compliance

Risk assessment

Global submissions

Education

Bachelor's degree in science

Master's degree in science

Job description

Novartis AG in Barcelona, Spain, seeks a Regulatory Manager, Maintenance and CTA, to lead regulatory submissions for clinical trial applications across an assigned portfolio, coordinating with study teams, country leads and cross-functional partners.

The role requires a science degree with 4+ years of regulatory experience, plus strong planning, submission, and labeling interpretation skills; Novartis emphasizes regulatory excellence, continuous improvement, and hybrid work options.