Senior Regulatory Scientist
Core
Senior Regulatory Scientist providing advanced regulatory and scientific expertise to support global clinical development strategies, submissions, and health authority interactions for new medicines.
Role type
Senior Regulatory Scientist (Clinical Development)
Builds
Clinical trial applications, briefing documents, major submission components, and regulatory strategies for global clinical programmes.
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy development, authoring and reviewing complex regulatory documents, interpreting global regulations (FDA, EMA, ICH), health authority interaction management, clinical development plan input, risk management strategy input, labelling considerations, mentoring junior staff, CMC document creation and consulting.
Preferred skills
Experience with Copilot for literature research.
Technologies
Microsoft Word, Excel, PowerPoint.
Responsibilities
Lead or contribute to regulatory strategy development; Author and review clinical trial applications and submission components; Interpret global regulations and advise cross-functional teams; Participate in health authority interactions; Provide regulatory input into clinical development plans and labelling; Mentor junior regulatory staff.
Seniority
Senior, hands-on IC with mentoring responsibilities.
