Regulatory Associate Manager, Maintenance and CTA

(FCRS = US014) Novartis Pharmaceuticals Corporation; Barcelona; Hybrid; EUR 36,000 - 67,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Job summary

Novartis Pharmaceuticals Corporation in Barcelona, Spain, is seeking a Regulatory Associate Manager, Maintenance and CTA. The role focuses on delivering lifecycle management submissions and maintaining regulatory compliance across an assigned portfolio.

You will work with regulatory leads and cross-functional teams to manage submissions, health authority interactions, and timely approvals. Fluent English and Spanish are required, with a degree in a scientific or healthcare discipline.

Qualifications

• Fluent English and Spanish with strong written and verbal skills.
• Degree in a scientific or healthcare discipline, or equivalent pharmaceutical expertise.
• Strong knowledge of regulatory requirements and lifecycle management processes.

Responsibilities

• Deliver high-quality lifecycle management submissions in line with regulatory requirements.
• Build product and local regulatory knowledge to support portfolio activities.
• Identify regulatory risks and trade-offs to minimise delays and enable timely approvals.
• Coordinate responses to health authority queries with clear regulatory justifications.
• Maintain accurate product information in regulatory databases and management systems.
• Support preparation and finalisation of health authority documentation.
• Contribute to continuous improvement and automation initiatives in Regulatory Affairs.

Skills

Regulatory knowledge

Cross-functional communication

English and Spanish fluency

Planning & organisation

Education

Degree in scientific or healthcare discipline

Job description

Salary Range:

€36,100.00 - €67,100.00

Job Description Summary

#LI-Hybrid

Location: Barcelona, Spain

Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support: please only apply if accessible.

Make an impact where science, strategy and execution come together. As Regulatory Associate Manager, Maintenance and CTA, you’ll help deliver high-quality regulatory activities across an assigned portfolio, supporting lifecycle management activities through to timely submission and approval. Working closely with regulatory leads and cross-functional teams, you’ll apply your regulatory knowledge to identify challenges, support health authority interactions and keep critical activities moving forward. You’ll also have the opportunity to contribute to continuous improvement and automation initiatives, helping us work smarter while delivering for patients.

Job Description

Key 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.

Essential Requirements

• 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.

Desirable Requirements

• Fluency in Portuguese.

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: £36,100 to £ 67,100

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering:

https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Skills Desired