Senior Regulatory Affairs Specialist

Bristol Myers Squibb

Australia
Hybrid (50% onsite)
3 years prescription medicine experience
Knowledge of australia/new zealand regulatory processes
Tertiary qualification in medicine pharmacy or life science
Bristol Myers Squibb is seeking a Senior Regulatory Affairs Specialist in Australia, responsible for managing regulatory activities related to product variations and compliance. The ideal candidate should possess relevant experience in regulatory affairs and a strong understanding of the pharmaceutical regulatory environment

Job Summary

  • This role plans and executes timely product variations and ensures regulatory compliance for Bristol Myers Squibb products supplied in Australia and New Zealand.
  • The position requires managing interactions with Health Authorities, maintaining regulatory files, and ensuring all GMP clearances are valid through timely filings.
  • Employees will work alongside high-achieving teams to transform patients' lives while enjoying competitive benefits and a flexible work environment.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Senior Regulatory Affairs Specialist in Australia, responsible for managing regulatory activities related to product variations and compliance. The ideal candidate should possess relevant experience in regulatory affairs and a strong understanding of the pharmaceutical regulatory environment.

Skills & Requirements

Must-have

  • 3 years prescription medicine experience
  • Knowledge of Australia/New Zealand regulatory processes
  • Tertiary qualification in medicine pharmacy or life science

Nice-to-have

  • Post graduate qualifications in pharmaceutical sciences
  • Ability to negotiate with global teams and Health Authorities
  • Experience in drug development from discovery to marketing

Key Requirements

  • 3 years relevant prescription medicine experience
  • Degree in medicine, pharmacy, or life science
  • Working knowledge of quality, manufacturing, and clinical research

Work Rights

Not specified

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