Regulatory Manager Team Lead
Core
Lead and manage the regulatory team in assigned markets, overseeing product lifecycle activities from pre- to post-authorisation and managing Marketing Authorisations.
Role type
Senior regulatory team lead (pharmaceuticals)
Builds
Regulatory strategies, submission plans, and product licenses for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Required skills
Cluster project management, team leadership, regulatory strategy development, cross-functional collaboration, stakeholder management, NRA engagement, compliance management, resource allocation
Preferred skills
Experience with EU national Scientific Advice Meetings, managing MA variations and renewals, handling NRA queries, supply of unlicensed medicines, divestments and discontinuations
Technologies
Regulatory databases, document management systems
Responsibilities
Lead and manage the regulatory team to achieve objectives; develop and deliver optimal regulatory strategies for country business goals; coordinate pre-submission meetings and manage interactions with National Regulatory Authorities; manage Marketing Authorisation applications (new, variations, renewals); respond to NRA queries and negotiate outcomes; support product divestments and discontinuations.
Seniority
Senior, hands-on IC with people management