Analista de Assuntos Regulatórios Pleno
New
BrazilFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Intermediate English
- Required Skills
- RESTful APIs
Requirements
- 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 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, and ability to manage multiple projects.
Responsibilities
- Monitor, interpret, and analyze national and international regulations and guidelines.
- Ensure regulatory compliance for APIs, biological products, medicines, and food ingredients.
- Prepare, review, and maintain regulatory dossiers submitted to health authorities.
- Develop and update technical documentation in CTD format, including Drug Master Files (DMF).
- Manage post-registration processes including variations, renewals, and compliance adjustments.
- Conduct regulatory intelligence activities to identify trends and risks.
- Provide technical support during internal audits, regulatory inspections, and customer audits.
- Coordinate information gathering with internal technical teams for regulatory submissions.
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