Regulatory Sciences Manager
Core
Develop and deliver optimal regulatory strategies for licensed and development products, manage national marketing authorisation applications, and advise cross-functional teams on compliance and legislation.
Role type
Senior IC regulatory sciences manager
Builds
New product licenses, marketing authorisation variations, and renewals for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic regulatory planning, national regulatory authority (NRA) engagement, marketing authorisation application management, compliance advisory, stakeholder management, database management, supply continuity management, third-party licence support, medical device regulatory support, good regulatory practice (GRP) adherence
Preferred skills
MBA or MS degree, line management experience, complex matrix environment navigation, therapeutic area knowledge
Technologies
Regulatory databases, document management systems
Responsibilities
Develop regulatory strategies for product portfolios, coordinate pre-submission meetings with NRAs, manage MA variation and renewal applications, respond to NRA queries, negotiate packaging and prescribing information updates, manage product divestments and discontinuations, support third-party licences and medical devices, maintain GRP compliance
Seniority
Senior, hands-on IC with management responsibilities
