Regulatory Affairs Manager

Trzdev36

Regulatory strategy development
Product license maintenance
Health authority relationship management
Develop and implement regulatory strategy for responsible therapeutic area to achieve rapid and high-quality approvals and facilitate rapid launch

Job Summary

  • Develop and implement regulatory strategy for responsible therapeutic area to achieve rapid and high-quality approvals and facilitate rapid launch.
  • Maintain product licenses to a high standard throughout the current year, ensuring zero negative impact to business objectives and financial targets.
  • Build excellent relationships and partnerships with Health Authorities and regulatory key external experts while contributing proactively to cross-functional business strategies.

Matching Summary

Develop and implement regulatory strategy for responsible therapeutic area to achieve rapid and high-quality approvals and facilitate rapid launch.

Skills & Requirements

Must-have

  • Regulatory strategy development
  • Product license maintenance
  • Health Authority relationship management
  • Regulatory compliance adherence
  • Cross-functional teamwork
  • Legal and patent management

Nice-to-have

  • Provisional Registered Pharmacist preceptor
  • Pharmacist and Poison A License holder
  • Monitoring global regulatory environment
  • Vendor and supplier management

Key Requirements

  • Pharmacy or scientific degree
  • Minimum 5 years regulatory affairs experience
  • Post-graduate qualification

Work Rights

Not specified

Tailored Resume

Cover Letter