Regulatory Affairs Fellow (12 months)
Core
Develop regulatory strategies for development and commercialization of pharmaceutical programs and marketed products.
Role type
Regulatory Affairs Fellow (PhD)
Builds
Regulatory strategies and submission applications for development programs
Domain
Biotechnology / Pharmaceutical Regulatory Affairs
Required skills
PhD in scientific background, complex scientific information assessment, regulatory strategy development, regulatory submission management, health authority communication, compliance with regulations, regulatory intelligence review
Preferred skills
None stated
Technologies
None stated
Responsibilities
Contribute to development and implementation of regulatory strategy, support regulatory strategy under guidance, manage preparation and submission of regulatory applications, provide technical regulatory input for product development documents, review regulatory intelligence and guidance information
Seniority
Entry-level Fellow (12 months)