The Regulatory Affairs area is strategic for the growth of the company. Through regulatory processes with ANVISA, the company expands and renews its portfolio.
The regulatory environment is constantly changing, requiring companies to be ready to anticipate them, analyze their impacts, plan and implement them in a timely and effective manner.
In addition, the Regulatory Affairs area is also responsible for ensuring that the company complies with the applicable health regulations in order to continue business, avoid penalties and protect the company's image.
The Regulatory Affairs Analyst should be prepared to work in this environment and deliver the expected results through teamwork, timely and quality.
Understands and fulfills current and local regulations and internal policies while assessing, planning and executing regulatory processes
Prepares regulatory low-mid complexity filings w / o major supervision
Assist on preparation of major filings under certain supervision
Formulates mitigation plans for regular issues, identifies impacted areas and processes and drives the process under supervision
Updates local labeling components, review and approve promotional materials in full adherence to the Company Core Data Sheets (CCDS), BMS policies and local applicable regulations.
Timely and accurately feeds systems, databases and archives.
Drives contacts and consultations with HA within his / her scope
Supports preparation and deployment of HA interactions
Participates in Trade Association meetings
Develops its own working plan taking accountability for timely completion of assigned functions
Takes full accountability for timely delivery of quality results, with reasonable sense of urgency and priority
Skills, Competencies and Knowledge
Ability to develop new projects, contingency plans and solution / mitigation of regulatory problems
Knowledge of the regulations applicable to new and biological drugs
Knowledge of Clinical Research regulations will be considered a differential
Ability to interact in all functions and geographies
Teamwork, interpersonal relationships, commitment and dynamism
Ability to communicate fluently (written and verbally) in English and Portuguese
Ability to organize / prioritize tasks