Junior Regulatory Affairs Analyst

Novartis; Santo Amaro; Hybrid; BRL 60.000 - 80.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Sales incentive bonus

Pension scheme

Share purchase scheme

Health insurance

Annual leave

Flexible work

Subsidized dining

Recognition scheme

Learning development

Zusammenfassung

Novartis AG is seeking a Junior Regulatory Affairs Analyst based in São Paulo, Brazil, with hybrid work options. The role supports regulatory submissions, lifecycle maintenance, and cross-functional collaboration to ensure ongoing compliance and product availability.

The ideal candidate holds a Pharmacy or life sciences degree, has at least 1 year in regulatory affairs, and demonstrates strong organizational and English language skills. Relocation is not offered.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

English proficiency

Regulatory knowledge

Attention to detail

Ausbildung

Degree in Pharmacy or life sciences

Jobbeschreibung

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 paragraph

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