Senior Regulatory Affairs Professional

Há 3 dias

São Paulo, São Paulo, Brasil beBeeCompliance Tempo inteiro
Regulatory Affairs Full Analyst

This is a challenging and rewarding role for an individual who is passionate about ensuring the highest standards of regulatory compliance in our industry.

Job Description:

The Regulatory Affairs Full Analyst will be responsible for working closely with cross-functional teams to plan, prepare, and execute regulatory processes that ensure the continuity of our operations in Brazil. This will involve assessing, planning, and executing non-asset specific regulatory processes required for registration renewal, HMP filings, new commercial presentations, and cancellation of registration of drug product presentation. Additionally, the analyst will assist in preparing major filings under certain supervision, such as BLA, NDA, LCM, and DDCM.

Required Skills and Qualifications:
  • Strong knowledge of local regulations and internal policies related to regulatory processes.
  • Ability to understand and fulfill current and local regulations and internal policies while assessing, planning, and executing regulatory processes.
  • Excellent communication and analytical skills.
Benefits:
  • Opportunity to work in a dynamic and fast-paced environment.
  • Chance to grow and thrive through opportunities uncommon in scale and scope.
  • Collaborative and diverse work environment.

Travel required: Yes

Direct reports: No

Objectives/Responsibilities Include:
  • Preparing comprehensive and timely responses to HA queries.
  • Providing SME support for product divestitures or deletions and secure proper regulatory actions required as result of the decision.
  • Preparing and submitting extemporaneous mandatory notifications (i.e., OOS, shortages, quality deviations, recalls, etc.) and following up on derived actions until completion.
  • Maintaining regulatory records fully accurate and updated in BMS databases.

Keywords: Regulatory Compliance, Pharmaceutical Industry, Brazil Operations

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