Regulatory Associate Manager, Maintenance and CTA

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

Job Description Summary

Salary Range: €36,100.00 - €67,100.00

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

Location: Barcelona, Spain

Relocation Support: This role is based in Barcelona, Spain. Novartis is unable to offer relocation support.

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

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.

• Insurance plans
• Retirement plans
• Wellbeing resources
• Global recognition programs
• Performance-based bonus depending on certain performance parameters.
• Flexible and hybrid working options, where possible
• 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

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

Skills Desired

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you.

Working together. Learning together. Thriving together.

Discover how you can join us in changing people’s lives.

In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov.