Associate Director, Regulatory Affairs

KalVista Pharmaceuticals

Salisbury, United Kingdom
On-site
Ind/nda/maa preparation and submission
Post approval maintenance activities
Fda health canada latam regulatory experience
KalVista Pharmaceuticals is seeking an Associate Director of Regulatory Affairs to support the development and commercialization of their rare disease therapies. This role involves regulatory submissions, compliance, and cross-functional collaboration within the company

Job Summary

  • The role involves supporting the preparation and submission of IND, NDA, and MAA documents while ensuring ongoing regulatory compliance in designated territories.
  • Candidates will serve as the regulatory lead for specific markets, collaborating with global leads and cross-functional teams including business development and pharmacovigilance.
  • The position requires maintaining compliance with KalVista's Quality Management System and industry GxP standards while contributing to regulatory intelligence processes.

Matching Summary

Match Score: 85

KalVista Pharmaceuticals is seeking an Associate Director of Regulatory Affairs to support the development and commercialization of their rare disease therapies. This role involves regulatory submissions, compliance, and cross-functional collaboration within the company.

Skills & Requirements

Must-have

  • IND/NDA/MAA preparation and submission
  • Post approval maintenance activities
  • FDA Health Canada LATAM regulatory experience
  • 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
  • Proven interdisciplinary team player
  • Willingness to share information openly
  • Bias for action and solution-oriented mindset

Key Requirements

  • Minimum of 10 years Regulatory Affairs experience
  • Degree in Chemistry Pharmacy or Biological Science
  • Experience with FDA Health Canada and LATAM submissions
  • Experience developing SOPs for post-commercial compliance

Work Rights

Not specified

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