Principal Regulatory Affairs Professional
Core
Lead regulatory strategy and document review for clinical trials from preclinical stages through registration, serving pharmaceutical and biotech clients globally.
Role type
Principal Regulatory Affairs Specialist (Clinical Trials)
Builds
Regulatory submissions, strategic advice, and compliant deliverables for product development
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, document review, ICH guidelines, clinical trial authorization, lifecycle management, budgeting, project management, training (via careerplan.io/jobs/R-01370800-principal-regulatory-affairs-professional-at-thermofisher)
Preferred skills
Local language proficiency, negotiation, business development
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Provide senior review of regulatory documents and submissions; Act as subject matter expert for regulatory strategy advice; Participate in project management and act as liaison with clients; Provide matrix/project leadership and training to junior team members; Ensure adherence to project budgets, time schedules, and scope of work; Contribute to business development activities including project budgeting/forecasting.