Senior Global Regulatory Scientist
Core
Providing high-level regulatory and scientific expertise to support global development strategies and submissions for clinical programmes.
Role type
Senior Global Regulatory Scientist
Builds
Global regulatory strategies, clinical trial applications, briefing books, and major submission components
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory affairs expertise, knowledge of global clinical development regulations (FDA, EMA, ICH), strategic input into clinical development plans, risk management strategies, labelling considerations, health authority interaction, mentoring
Preferred skills
None stated
Technologies
None stated
Responsibilities
Leading development of global regulatory strategies, authoring and reviewing complex regulatory documents, interpreting evolving global regulations, providing strategic input into clinical development plans, representing regulatory functions in sponsor and health authority meetings, mentoring junior regulatory colleagues
Seniority
Senior, hands-on IC with mentoring responsibilities