Bristol Myers Squibb REGULATORY ANALYST in Sao Paulo, Brazil

Summary:

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.

The position is in full compliance with BMS laws, regulations, policies and procedures, including business rules, as well as BMS Conduct and Ethics

Primary objectives include, but are not limited to:

  • Understands and fulfills current and local regulations and internal policies, as well as the extent of impact of evolving changes, while assessing, planning and executing regulatory processes.

  • Prepares any type of regulatory filings (registration, post-approval variation and DDCM for biological and synthetic drugs; GMP certificates and sanitary licenses submission and renewal) without supervision.

  • Understands and formulates options for regular or exceptional issues, being able to propose mitigation / contingency plans and drive execution. He/she does not make decision on this matter.

  • Prepares and updates local labeling components, reviews and approves promotional materials in full adherence to the BMS policies and local applicable regulations.

  • Timely and accurately feeds systems, databases and archives.

  • Drives contacts and consultations with the HA within his/her area of responsibility, including technical – operational HA interactions

  • Participates in external forums as might be required and represents the company upon designation

  • Develops its own working plan taking full accountability for resource allocation, timely and quality results within his/her function, adequately

CONNECTIVITY

  • Connects and collaborates across the local, regional and global functions as required

  • Builds personal credibility and strong working relationships

  • Focus on patient and customer needs to drive results

  • Learns and shares best practices across the function

  • Demonstrates commitment to timely deliver quality results

Education:Bachelor degree in Pharmacy.Experience:• Experience in the regulatory area for at least 5 years in the various types of regulatory processes: preparation of new product registration, post registration, renewal, maintenance of records and administrative documents (GMP certificate, Licenses, etc.) and routine regulatory activities.• Previous experience with biological drugs is mandatory.• Previous knowledge about DDCM is desirableSkills, 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

CONNECTIVITY

  • Connects and collaborates across the local, regional and global functions as required

  • Builds personal credibility and strong working relationships

  • Focus on patient and customer needs to drive results

  • Learns and shares best practices across the function

  • Demonstrates commitment to timely deliver quality results

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