Junior Regulatory Affairs Analyst

BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A; Santo Amaro; Hybrid; BRL 60,000 - 90,000; Full time

Benefits offered by this job

Health insurance

25 days annual leave

Flexible working arrangements

Learning and development opportunities

Job summary

Novartis Biociencias S.A. in São Paulo, Brazil is seeking a Junior Regulatory Affairs Analyst to support timely and compliant lifecycle submissions and maintain product registrations.

You will collaborate with cross-functional teams to ensure alignment with evolving regulatory requirements and contribute to ongoing regulatory compliance in a global organisation. The role involves preparing dossiers, maintaining documentation, and guiding internal stakeholders on regulatory timelines.

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.
• Professional working proficiency in English.

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 affairs

English proficiency

Education

Pharmacy degree

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.

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

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.