Analista De Assuntos Regulatórios Júnior (prazo Determinado 12 Meses)
GSK
Rio de Janeiro, RJ, Brazil
Regulatory documentation preparation
Submission schedule organization
Regulatory authority liaison
As a Junior Regulatory Affairs Analyst, you will be responsible for preparing and reviewing regulatory documentation, organizing submission schedules and controls, tracking processes with regulatory authorities (e.g., ANVISA), and supporting the maintenance of records and electronic repositories
Job Summary
As a Junior Regulatory Affairs Analyst, you will be responsible for preparing and reviewing regulatory documentation, organizing submission schedules and controls, tracking processes with regulatory authorities (e.g., ANVISA), and supporting the maintenance of records and electronic repositories.
You will collaborate with Quality Assurance, Supply Chain, Medical Affairs, and Legal departments, contributing to the continuous improvement of regulatory processes and compliance with established standards and deadlines.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together, aiming to positively impact the health of 2.5 billion people by the end of the decade.
Matching Summary
As a Junior Regulatory Affairs Analyst, you will be responsible for preparing and reviewing regulatory documentation, organizing submission schedules and controls, tracking processes with regulatory authorities (e.g., ANVISA), and supporting the maintenance of records and electronic repositories.
Skills & Requirements
Must-have
regulatory documentation preparation
submission schedule organization
regulatory authority liaison
electronic submission systems
quality management system alignment
Nice-to-have
continuous process improvement
cross-functional collaboration
proactive problem-solving
ambitious and impactful work environment
Key Requirements
University degree in Pharmacy, Chemistry, Biomedicine, Biology or related fields
Basic knowledge of post-registration and drug registration processes
Familiarity with Anvisa electronic submissions
Intermediate Excel skills and document management systems
Intermediate English for technical reading and global team interaction