Lead Regulatory Affairs

AstraZeneca

Not specified
Regulatory strategies
Clinical trials
Regulatory compliance
AstraZeneca is seeking a Lead Regulatory Affairs professional to manage regulatory strategies and ensure compliance for assigned franchises, focusing on innovative products and clinical trials. The ideal candidate should possess a pharmacy degree, people management experience, and expertise in regulatory affairs, particularly in India

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: 85

AstraZeneca is seeking a Lead Regulatory Affairs professional to manage regulatory strategies and ensure compliance for assigned franchises, focusing on innovative products and clinical trials. The ideal candidate should possess a pharmacy degree, people management experience, and expertise in regulatory affairs, particularly in India.

Skills & Requirements

Must-have

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

Nice-to-have

  • patient-focused biopharmaceutical
  • science-led company
  • lifelong learning
  • inclusive culture
  • diversity and collaboration

Key Requirements

  • Pharmacy graduate
  • People management experience
  • Regulatory expertise in innovative treatment modalities

Work Rights

Not specified

Tailored Resume

Cover Letter