Bristol Myers Squibb SENIOR REGULATORY ANALYST in Sao Paulo, Brazil
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 major 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 balancing urgency and priority.
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
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled