Regulatory Associate Manager: Lifecycle & Submissions

Novartis AG; Barcelona; On-site; EUR 43,000 - 80,000; Full time

Job summary

Novartis AG in Barcelona, Spain, seeks a Regulatory Associate Manager, Maintenance and CTA, to deliver high-quality regulatory activities across an assigned portfolio. You will support lifecycle management and health authority interactions, working with regulatory leads and cross-functional teams to move critical activities forward.

The role emphasizes regulatory expertise, clear communication, and continuous improvement, with opportunities to contribute to automation initiatives and global

Qualifications

• Fluent English and Spanish with strong written and verbal communication skills.
• Degree in a scientific or healthcare discipline, or equivalent relevant pharmaceutical industry expertise.
• 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

English fluency

Spanish fluency

Regulatory knowledge

Education

Scientific/healthcare degree

Job description

Novartis AG in Barcelona, Spain, seeks a Regulatory Associate Manager, Maintenance and CTA, to deliver high-quality regulatory activities across an assigned portfolio. You will support lifecycle management and health authority interactions, working with regulatory leads and cross-functional teams to move critical activities forward.

The role emphasizes regulatory expertise, clear communication, and continuous improvement, with opportunities to contribute to automation initiatives and global