Junior Regulatory Affairs Analyst

Novartis; Schweiz; On-site; CHF 9,100 - 14,000; Full time

Benefits offered by this job

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

Job summary

Novartis AG in São Paulo, Brazil seeks a Junior Regulatory Affairs Analyst to support timely regulatory submissions and ongoing compliance. You will assist with dossier preparation, documentation maintenance, and alignment with local and international requirements within a global organisation.

This role offers exposure to ANVISA and other authorities, cross‑functional collaboration, and growth in regulatory expertise, with no relocation support and a flexible, inclusive workplace.

Qualifications

• Degree in Pharmacy or a related life sciences discipline.
• Minimum of 1 year of experience in regulatory affairs.
• Working knowledge of local and international regulatory legislation and submission requirements.
• Experience in preparing regulatory dossiers and lifecycle maintenance activities.
• Strong organisational skills and ability to manage multiple tasks.
• Professional working proficiency in English.

Responsibilities

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

Skills

Regulatory knowledge

Dossier preparation

Documentation maintenance

English proficiency

Multi‑tasking

Education

Degree in Pharmacy or life sciences

Job description

Job Description Summary

#LI-Hybrid

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.

Job Description

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.