Associate Director, Regulatory Affairs

KalVista Pharmaceuticals

Salisbury, United Kingdom
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Ind/nda/maa preparation and submission experience
Post approval maintenance activities expertise
Fda health canada latam regulatory knowledge
** KalVista Pharmaceuticals is seeking an Associate Director of Regulatory Affairs to join their team in Salisbury, UK. The role involves leading regulatory submissions and ensuring compliance for product commercialization, specifically focusing on rare diseases. **

Job Summary

  • The role involves supporting the development of regulatory submissions and ensuring ongoing compliance for KalVista's life-changing oral therapies.
  • Candidates will serve as the regulatory lead for designated territories while collaborating with global teams on pre and post-approval activities.
  • The position requires maintaining compliance with industry standards of GxP and contributing to the company's Regulatory Intelligence process.

Matching Summary

Match Score: 75

** KalVista Pharmaceuticals is seeking an Associate Director of Regulatory Affairs to join their team in Salisbury, UK. The role involves leading regulatory submissions and ensuring compliance for product commercialization, specifically focusing on rare diseases. **

Skills & Requirements

Must-have

  • IND/NDA/MAA preparation and submission experience
  • Post approval maintenance activities expertise
  • FDA Health Canada LATAM regulatory knowledge
  • SOP development for regulatory compliance
  • Cross-functional collaboration with commercial teams

Nice-to-have

  • Outstanding written and verbal communication skills
  • Ability to manage projects under tight deadlines
  • Strong team player with interdisciplinary experience
  • Willingness to share information openly

Key Requirements

  • Minimum 10 years Regulatory Affairs experience
  • Degree in Chemistry Pharmacy or Biological Science
  • Experience with FDA Health Canada and LATAM submissions
  • Proven ability to develop SOPs for compliance

Work Rights

Not specified

Tailored Resume

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