Regulatory Affairs Manager

Zse68

Adherence to az and industry codes
Product license maintenance
Develop regulatory strategy
Develop & implement regulatory strategy for responsible therapeutic area to achieve rapid & high-quality approvals & facilitate rapid launch

Job Summary

  • Develop & implement regulatory strategy for responsible therapeutic area to achieve rapid & high-quality approvals & facilitate rapid launch.
  • Monitor & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key stakeholders.
  • AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.

Matching Summary

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

Skills & Requirements

Must-have

  • Adherence to AZ and industry codes
  • Product license maintenance
  • Develop regulatory strategy
  • Monitor regulatory environment
  • Manage legal and patent matters
  • Act as Company Pharmacist

Nice-to-have

  • Proactive cross-functional teamwork
  • Excellent relationships with Health Authorities
  • Embraces diversity and equality

Key Requirements

  • Pharmacy or Scientific Degree
  • Minimal 5 years regulatory affairs experience
  • Post-graduate qualification
  • Provisional Registered Pharmacist (PRP) Preceptor

Work Rights

Not specified

Tailored Resume

Cover Letter