Associate Director, International Regulatory Strategy

KalVista Pharmaceuticals, Inc.; Salisbury; On-site; GBP 70,000 - 90,000; Full time

Job summary

A global pharmaceutical company is seeking an Associate Director, Regulatory Affairs to lead international regulatory strategies. This mid-senior position requires extensive experience in regulatory affairs and offers opportunities to work on post-approval activities and compliance processes. The role involves close collaboration with various departments to ensure successful product commercialization.

Qualifications

• Minimum of 10 years’ experience in Regulatory Affairs.
• Experience with Centralized Marketing Authorization Applications.
• Strong ability to manage projects while meeting tight deadlines.

Responsibilities

• Support international MAA submission and post-approval activities.
• Represent regulatory affairs in allocated launch teams.
• Provide regulatory support to business development and commercial teams.

Skills

Regulatory Affairs experience

Communication skills

Project management

Collaboration in interdisciplinary teams

Education

BSc in Chemistry, Pharmacy, or Biological Science

Job description

A global pharmaceutical company is seeking an Associate Director, Regulatory Affairs to lead international regulatory strategies. This mid-senior position requires extensive experience in regulatory affairs and offers opportunities to work on post-approval activities and compliance processes. The role involves close collaboration with various departments to ensure successful product commercialization.