Regulatory Affairs Specialist

1 dia atrás

São Paulo, São Paulo, Brasil Bristol Myers Squibb Tempo inteiro
Join Our Team at Bristol Myers Squibb

We are seeking a highly skilled Regulatory Affairs Full Analyst to join our team at Bristol Myers Squibb. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the company's compliance with health regulations and maintaining a strong reputation in the industry.

About the Role

The Regulatory Affairs Full Analyst will be responsible for planning, preparing, and submitting regulatory processes required for the continuity of BMS operations in Brazil. This includes GMP certificates, operating authorization, and working license maintenance, as well as Pharmaceutical Council Documentation. You will also be responsible for preparing registration renewal, HMP, and regulatory low-mid complexity filings without major supervision.

Key Responsibilities
  • Understand and fulfill current and local regulations and internal policies while assessing, planning, and executing regulatory processes.
  • Prepare and submit extemporaneous mandatory notifications (i.e. OOS, shortages, quality deviations, recalls, etc.) and follow up on derived actions until completion.
  • Feed in a timely basis BMS databases to maintain regulatory records fully accurate and updated (PRISM/CARA, Verity, SharePoints, PSUR reports, etc.).
  • Create local labeling in full adherence to target labeling.
Requirements

To be successful in this role, you will need to have a strong understanding of regulatory processes and procedures, as well as excellent communication and teamwork skills. You will also need to be able to work in a fast-paced environment and prioritize multiple tasks and deadlines.

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual who is passionate about regulatory affairs, we encourage you to apply for this exciting opportunity.

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