Senior Regulatory Affairs Manager

Sanofi Genzyme

Sydney, Australia
Hybrid
Strong regulatory affairs experience in pharmaceutical industry
Experience with tga and medsafe regulatory processes
Proven stakeholder management skills in matrix environments
The role involves developing and implementing regulatory strategies to accelerate access to new products and optimize the value of the existing portfolio

Job Summary

  • The role involves developing and implementing regulatory strategies to accelerate access to new products and optimize the value of the existing portfolio.
  • Candidates must engage with health authorities like the TGA and Medsafe to ensure optimal business outcomes and timely approvals.
  • Sanofi offers a flexible hybrid working environment designed to support professional growth alongside experienced leaders committed to innovation.

Matching Summary

The role involves developing and implementing regulatory strategies to accelerate access to new products and optimize the value of the existing portfolio.

Skills & Requirements

Must-have

  • Strong Regulatory Affairs experience in pharmaceutical industry
  • Experience with TGA and Medsafe regulatory processes
  • Proven stakeholder management skills in matrix environments
  • Ability to independently manage complex regulatory activities
  • Leadership experience managing and coaching team members

Nice-to-have

  • Strategic and execution-focused mindset
  • Contribution to industry groups and consultations
  • Cross-functional collaboration within global teams
  • Commitment to patient-centric approach and safety culture

Key Requirements

  • Bachelor's degree in Life Sciences, Pharmacy, or related scientific discipline
  • Strong Regulatory Affairs experience within pharmaceutical or biotechnology sector
  • Experience working with Australian (TGA) and New Zealand (Medsafe) regulatory bodies

Work Rights

Not specified

Tailored Resume

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