Regulatory Affairs Manager

Novartis UK

Unknown, United Kingdom
Not specified; not specified; not specified
Regulatory strategy implementation
Health authority interactions
Dossier submission management
The role directs the development of product registration submissions and provides strategic direction to teams on interacting with regulatory agencies

Job Summary

  • The role directs the development of product registration submissions and provides strategic direction to teams on interacting with regulatory agencies.
  • The incumbent is responsible for implementing global regulatory strategies, managing operational activities, and ensuring timely approvals for new drugs and devices.
  • Key duties include facilitating Health Authority interactions, reviewing Clinical Trial Applications, and leading negotiations to avoid project delays.

Matching Summary

The role directs the development of product registration submissions and provides strategic direction to teams on interacting with regulatory agencies.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Regulatory strategy implementation
  • Health Authority interactions
  • Dossier submission management
  • Clinical trial application review
  • Risk management plan development

Nice-to-have

  • Cross-cultural experience
  • Negotiation skills with agencies
  • Project management expertise
  • Detail-oriented approach
  • Global regulatory knowledge

Key Requirements

  • Functional breadth in regulatory affairs
  • Operations management and execution skills
  • Experience with drug development lifecycles
  • Proficiency in regulatory compliance standards
  • Strong negotiation and communication abilities

Work Rights

Not specified

Tailored Resume

Cover Letter