Analista de Assuntos Regulatórios Pleno

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Analista de Assuntos Regulatórios Pleno based in Brazil.

This role offers the opportunity to contribute to regulatory excellence within a dynamic environment focused on innovation, quality, and compliance.
The professional will play a key role in ensuring that products and processes meet national and international regulatory requirements.
You will work closely with multidisciplinary teams, supporting strategic decisions and enabling business growth through regulatory expertise.
The position involves managing complex documentation, regulatory submissions, and compliance initiatives across different product categories.
The ideal candidate is detail-oriented, analytical, and passionate about translating regulatory requirements into practical business solutions.
This is an opportunity to make a meaningful impact while developing expertise in a highly regulated industry.

Accountabilities:

The professional will be responsible for managing regulatory activities, ensuring compliance with applicable standards, and supporting product development and business continuity through strategic regulatory guidance.

• Monitor, interpret, and analyze national and international regulations, guidelines, and regulatory updates, assessing their potential impact on business activities.
• Ensure regulatory compliance for active pharmaceutical ingredients (APIs), biological products, medicines, ingredients, food additives, and food products according to applicable requirements.
• Prepare, review, and maintain regulatory dossiers submitted to health authorities and regulatory agencies.
• Develop and update technical documentation in CTD format, including Drug Master Files (DMF) and other regulatory materials.
• Support regulatory feasibility assessments for new projects, products, and process changes.
• Manage post-registration regulatory processes, including variations, updates, renewals, and compliance adjustments.
• Conduct regulatory intelligence activities by identifying trends, opportunities, and risks that support business strategies.
• Identify and mitigate regulatory risks by proposing technical solutions and compliance actions.
• Coordinate information gathering with internal technical teams to prepare submissions, reports, and regulatory documentation.
• Manage renewals of licenses, permits, certifications, authorizations, and other mandatory regulatory documents.
• Provide technical support during internal audits, regulatory inspections, and customer audits.
• Act as a key interface between internal stakeholders and regulatory authorities, ensuring technical alignment and effective communication.

Requirements:

The ideal candidate should have experience in regulatory affairs within regulated industries, strong technical knowledge, and the ability to manage documentation and compliance processes with accuracy and ownership.

• Bachelor’s degree in Pharmacy, Biotechnology, or related fields.
• Professional experience in Regulatory Affairs within the pharmaceutical industry.
• Experience managing regulatory processes with ANVISA or similar regulatory authorities.
• Knowledge of preparing regulatory dossiers and technical documentation in CTD/DMF formats.
• Understanding of regulations applicable to active pharmaceutical ingredients (APIs), especially biological-origin products.
• Experience performing regulatory impact assessments and compliance evaluations.
• Intermediate English skills, with the ability to read, write, and interpret technical documents.
• Strong analytical skills, attention to detail, organization, and ability to manage multiple regulatory projects.
• Ability to collaborate effectively with cross-functional teams and communicate technical information clearly.

Benefits:

• Hybrid work model with corporate base in São Paulo and remote work flexibility.
• Opportunity to work in a company focused on innovation, quality, and sustainable growth.
• Inclusive workplace culture that values diversity and equal opportunities.
• Professional development opportunities within a regulated and constantly evolving industry.
• Exposure to national and international regulatory processes.
• Collaboration with multidisciplinary teams across different business areas.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1