Lead Regulatory Affairs

AstraZeneca

**
Regulatory strategies
Clinical trials
Regulatory compliance
** AstraZeneca is seeking a Lead Regulatory Affairs professional to oversee regulatory strategies and compliance for assigned franchises, from clinical development to life cycle maintenance. The ideal candidate will have a pharmacy background, people management experience, and expertise in regulatory affairs, especially in innovative treatment modalities. **

Job Summary

  • Lead regulatory affairs for assigned franchise from clinical development up to life cycle maintenance, preparing regulatory strategies including risk mitigation plans for accelerated regulatory approvals of new products and clinical trials.
  • Ensure ~100% regulatory compliance as per internal and external expectations including post approval commitments, labelling, site transfers, and biologicals, with in-depth knowledge of Indian regulations essential.
  • At AstraZeneca, you are empowered to push the boundaries of science and unleash your entrepreneurial spirit, in an inclusive culture that champions diversity and collaboration.

Matching Summary

Match Score: 75

** AstraZeneca is seeking a Lead Regulatory Affairs professional to oversee regulatory strategies and compliance for assigned franchises, from clinical development to life cycle maintenance. The ideal candidate will have a pharmacy background, people management experience, and expertise in regulatory affairs, especially in innovative treatment modalities. **

Skills & Requirements

Must-have

  • regulatory strategies
  • clinical trials
  • regulatory compliance
  • Indian regulations
  • cross-functional collaboration
  • people management responsibility

Nice-to-have

  • innovative treatment modalities
  • regulatory policy shaping
  • Health Authority advocacy
  • lifelong learning
  • inclusive culture

Key Requirements

  • Pharmacy graduate
  • People management experience
  • Post-graduate qualification in Pharmacy
  • Experience in regulatory affairs
  • Experience in drug development
  • Experience in clinical trials

Work Rights

Not specified

Tailored Resume

Cover Letter