Contribute to the definition of global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority interactions
Job Summary
Contribute to the definition of global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority interactions.
Provide regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams, working flexibly within and across regions.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Matching Summary
Contribute to the definition of global regulatory strategy and drive the execution of aligned US, EU, and/or global regulatory strategies for assigned projects, including Health Authority interactions.
Skills & Requirements
Must-have
Global regulatory strategies
Health Authority interactions
Rare Diseases therapeutic area
Electronic document management systems
EU or US regulatory experience
Nice-to-have
Proactive contributor with curiosity
Strong business acumen
Adaptability to digital regulatory landscapes
Experience with biologics
AI and GenAI enabled applications
Key Requirements
Minimum 6 years pharmaceutical/biotechnology industry experience
Minimum 4 years Regulatory Affairs experience
BS/BA degree in a relevant scientific discipline, or PharmD, MSc