Analista de Assuntos Regulatórios Sr - foco na viabilidade de projetos

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Affairs Analyst – Project Feasibility Focus in Brazil.

This role plays a key part in shaping the regulatory and clinical viability of new pharmaceutical projects, ensuring that innovative products can successfully move through complex approval pathways. You will work at the intersection of regulatory strategy, clinical research, and medical information, contributing directly to decisions that impact the development and registration of new medicines. The position involves evaluating project feasibility, defining regulatory routes, and supporting due diligence processes for international partnerships. You will also collaborate with multidisciplinary teams and external stakeholders, including regulatory authorities, to ensure alignment with evolving guidelines and requirements. The environment is highly technical, collaborative, and innovation-driven, with strong exposure to strategic regulatory discussions. This is a great opportunity for a senior professional looking to influence high-impact decisions in the pharmaceutical development lifecycle.

Accountabilities:

• Assess the scope and regulatory feasibility of new projects, defining the appropriate clinical-regulatory pathway in collaboration with clinical research, bioequivalence, and medical teams.
• Conduct due diligence on international partner dossiers to validate regulatory strategies and identify potential risks.
• Provide regulatory guidance to internal and external stakeholders, ensuring compliance with ANVISA regulations and international guidelines.
• Represent the organization in technical discussions with industry associations and regulatory bodies, contributing to public consultations and regulatory developments.
• Analyze the impact of new regulations and consolidate cross-functional inputs to support strategic decision-making.
• Support the development and continuous improvement of regulatory processes and internal technical frameworks.
• Facilitate internal training and knowledge sharing on regulatory topics and evolving requirements.

Requirements:

• Bachelor’s degree in Pharmacy, Biochemistry, Chemistry, Biology, or Biomedicine.
• Intermediate to advanced English proficiency.
• Strong experience in regulatory project feasibility, including defining clinical-regulatory pathways for product registration.
• Solid knowledge of ANVISA requirements and international regulatory guidelines (ICH, EMA, FDA).
• Proven experience with synthetic drug registration in Brazil.
• Advanced proficiency in Microsoft Office tools.
• Strong analytical thinking, communication skills, and ability to work in multidisciplinary environments.
• Nice to have: postgraduate studies in Regulatory Affairs, Biotechnology, Clinical Research, or Project Management.
• Experience with biologics (e.g., monoclonal antibodies, vaccines), licensed products, or other regulated categories such as medical devices or food.
• Knowledge of CTD format and project management methodologies.

Benefits:

• Flexible remote work model with base location in São Paulo.
• Flexible working hours (entry between 7:00–9:00 and exit between 16:00–18:00).
• Meal and food allowances (Vale Refeição and Vale Alimentação).
• Health, dental, life insurance, and private pension plan.
• Pharmacy benefit program and access to discounted medications.
• Profit-sharing program (PPR).
• Home office support through equipment subsidy program.
• Transportation support where applicable (parking, transport allowance, or shuttle).
• Flexible benefit package including wellness platforms and additional support services.
• Strong focus on employee well-being, development, and long-term career growth in a recognized workplace culture.

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