Regulatory Submissions Lead

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.; Sabadell; On-site; EUR 36,000 - 67,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Performance-based bonus

Flexible/hybrid working

Parental leave (14 weeks)

Job summary

Novartis AG in Barcelona, Spain, is seeking a Regulatory Affairs professional to manage lifecycle submissions and maintain robust regulatory knowledge for assigned products. You will coordinate responses to health authority inquiries, ensuring clear justifications and compliant documentation.

The role requires fluency in English and Spanish, a science/healthcare degree, and experience with regulatory submissions and cross-functional collaboration. Hybrid work options may be available.

Qualifications

• Fluent English and Spanish with strong written and verbal communication skills.
• Degree in scientific or healthcare discipline.
• Strong knowledge of regulatory requirements, guidelines and processes supporting lifecycle management and clinical trial applications.
• Experience supporting regulatory submissions, approvals, compliance and interactions with health authorities.
• Ability to interpret safety and efficacy data and understand product labelling requirements.
• Strong planning, organisational and communication skills, with the ability to work effectively across global, cross-functional teams.

Responsibilities

• Deliver high-quality lifecycle management submissions in line with regulatory requirements.
• Build strong product and local regulatory knowledge to support assigned portfolio activities.
• Identify regulatory risks, gaps and trade-offs, helping minimise delays and enable timely approvals.
• Coordinate timely responses to health authority queries, supporting clear and robust regulatory justifications.
• Maintain accurate product information within regulatory compliance databases 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.

Skills

Fluent English

Fluent Spanish

Regulatory knowledge

Cross-functional collaboration

Education

Science/Healthcare degree

Tools

Regulatory databases

Job description

Novartis AG in Barcelona, Spain, is seeking a Regulatory Affairs professional to manage lifecycle submissions and maintain robust regulatory knowledge for assigned products. You will coordinate responses to health authority inquiries, ensuring clear justifications and compliant documentation.

The role requires fluency in English and Spanish, a science/healthcare degree, and experience with regulatory submissions and cross-functional collaboration. Hybrid work options may be available.