Regulatory Portfolio Management Specialist

19 hours ago


Hyderabad, Telangana, India Bristol Myers Squibb Full time
Job Summary

We are seeking a highly skilled Regulatory Portfolio Management Specialist to join our team at Bristol Myers Squibb. As a key member of our regulatory team, you will be responsible for providing global regulatory support and strategy to ensure compliance with regulatory requirements.

Key Responsibilities
  • Co-lead GRST meetings to ensure high-quality discussions and decisions
  • Liaise cross-functionally to generate periodic internal milestone reports
  • Communicate status and timeline changes
  • Track key regulatory milestones and health authority meetings
  • Monitor key health authority websites for pertinent information
  • Compile regulatory precedents as requested
  • Create and support databases for global submission country requirements
  • Support CMC leads to gather auxiliary documentation for clinical and commercial submissions
  • Support submission team meetings and product divestitures
  • Schedule RRT meetings and communicate timelines
  • Set up response templates to ensure submission readiness
  • Follow up with SMEs in response sections
  • Support preparation of GRS analytics and monthly dashboards
  • Review Verity and Infinity reports for compliance-related trends

Requirements
  • Minimum of a Bachelor's degree in a natural science, pharmacy, or other healthcare-related field
  • At least 3 years of experience in the pharmaceutical industry and regulatory affairs
  • Solid understanding of major health authority regulations and regulatory standards
  • Excellent communication and organizational skills
  • Ability to lead cross-functional teams and make decisions in their sphere of influence
  • Proficiency in standard office technology, including Microsoft Suite

About Us

Bristol Myers Squibb is a global biopharmaceutical company dedicated to transforming patients' lives through science. We are committed to innovation, urgency, accountability, inclusion, and integrity. If you are passionate about making a difference in the lives of patients, we encourage you to apply for this exciting opportunity.

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