International Regulatory Affairs Lead - Submissions & Strategy

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

Job summary

A global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to lead regulatory compliance for international markets. The role includes managing regulatory submissions, representing the regulatory team in launch activities, and collaborating across various functions. Candidates should have a BSc in relevant sciences and at least 10 years in Regulatory Affairs, with strong communication and project management skills.

Qualifications

• Minimum 10 years in Regulatory Affairs.
• Experience with Centralised Marketing Authorization Applications.
• Ability to execute projects under tight deadlines.

Responsibilities

• Support international MAA submission and post-approval activities.
• Represent regulatory affairs in launch teams.
• Draft processes to ensure ongoing regulatory compliance.

Skills

Outstanding communication skills

Project management

Team player

Regulatory compliance knowledge

Education

BSc in Chemistry, Pharmacy or Biological Science

Job description

A global pharmaceutical company is seeking an Associate Director of Regulatory Affairs to lead regulatory compliance for international markets. The role includes managing regulatory submissions, representing the regulatory team in launch activities, and collaborating across various functions. Candidates should have a BSc in relevant sciences and at least 10 years in Regulatory Affairs, with strong communication and project management skills.