Regulatory Affairs Group Director, International Regulatory Affairs
Core
Lead a team of Regulatory Affairs professionals to secure first Marketing Authorisation Applications (MAAs), clinical line extensions, and lifecycle maintenance activities for new medicines in international markets.
Role type
Senior IC Regulatory Affairs Group Director (International)
Builds
Regulatory submissions and approvals for new medicines in international markets
Domain
Biopharmaceuticals / International Regulatory Affairs
Required skills
International regulatory strategy, team leadership, project resourcing, cross-functional collaboration, change management, stakeholder engagement, regulatory operating model expertise, MAA/CLE/LCM lifecycle knowledge
Preferred skills
Industry association representation, external advocacy, process improvement, knowledge sharing culture development
Technologies
None stated
Responsibilities
Provide leadership and coaching to direct reports across different geographies; Develop international market organisational capability and promote knowledge sharing; Attract and recruit talent; Contribute to group strategy and deliver performance targets; Manage resourcing for TA projects with international market iRAMs; Ensure compliance with AZ standards and policies; Lead continuous improvement initiatives; Represent the business externally in industry associations or advocacy programmes
Seniority
Director, hands-on leadership & strategy