Junior Regulatory Affairs Analyst

Novartis Brasil; São Paulo; On-site; BRL 50,000 - 70,000; Full time

Benefits offered by this job

Health insurance

Pension scheme

25 days annual leave

Dining facilities

Job summary

Novartis Brasil in São Paulo is seeking a Junior Regulatory Affairs Analyst to support lifecycle submissions and regulatory compliance across local and international requirements. You will collaborate with cross-functional teams to maintain product registrations and ensure timely approvals.

This role offers the opportunity to build regulatory expertise within a global organization committed to improving patients' lives, with a focus on ANVISA processes and global health authority alignment.

Qualifications

• Degree in Pharmacy or related life sciences.
• At least 1 year of regulatory affairs experience.
• Knowledge of local and international regulatory legislation and submission requirements.
• Experience preparing regulatory dossiers and lifecycle maintenance activities.
• Strong organizational skills and ability to manage multiple tasks.
• Professional working proficiency in English, both written and spoken.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for renewals and variations.
• Review technical documentation to ensure compliance with local and international regulatory requirements.
• Prepare and maintain regulatory documentation and legal certificates.
• Provide guidance to internal stakeholders on regulatory requirements, timelines, and documentation.
• Maintain accurate regulatory databases, tracking systems, and activity records.
• Ensure consistent compliance with internal procedures, regulatory standards, and submission deadlines.

Skills

Regulatory knowledge

Attention to detail

English proficiency

Organizational skills

Communication

Education

Pharmacy degree

Job description

Summary

São Paulo, Brazil

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

Drive regulatory excellence where it truly matters. As a Junior Regulatory Affairs Analyst, you will contribute to maintaining product registrations and ensuring ongoing regulatory compliance by supporting timely and compliant lifecycle submissions. Working within Regulatory Affairs, you will collaborate with cross-functional teams to support post-approval activities, prepare and maintain regulatory documentation, and ensure alignment with evolving local and international regulatory requirements. This is a great opportunity to build your regulatory expertise while contributing to the continued availability of medicines to patients within a global organisation committed to improving lives.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for renewals and variations
• Review technical documentation to ensure compliance with local and international regulatory requirements
• Prepare and maintain regulatory documentation and legal certificates
• Provide guidance to internal stakeholders on regulatory requirements, timelines, and documentation
• Maintain accurate regulatory databases, tracking systems, and activity records
• Ensure consistent compliance with internal procedures, regulatory standards, and submission deadlines

Essential Requirements

• Degree in Pharmacy or a related life sciences discipline
• Minimum of 1 year of experience in regulatory affairs within the pharmaceutical or healthcare industry
• Working knowledge of local and international regulatory legislation and submission requirements
• Experience in preparing regulatory dossiers and supporting lifecycle maintenance activities
• Strong organisational skills, with the ability to manage multiple tasks and priorities
• Professional working proficiency in English, both written and spoken

Desirable Requirements

• Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or healthcare industry
• Advanced proficiency in English, supporting effective communication with global stakeholders
• Experience in regulatory affairs within Brazilian health authority frameworks, including submission to ANVISA

Benefits & Rewards

Competitive salary, Sales incentive bonus, Pension scheme, Share purchase scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

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.

Why Novartis:

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards:

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