Competitive remuneration; annual incentive plan bo...
Local regulatory submission preparation
Ethical committee and moh alignment
Site start-up activity coordination
The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals in alignment with global strategies
Job Summary
The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals in alignment with global strategies.
Candidates will serve as the key contact at the country level for submission-related activities and ensure alignment with critical path timelines for site activation.
Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and outstanding career development prospects within a culture of integrity and innovation.
Matching Summary
The role involves preparing and coordinating local regulatory submissions including MoH and Ethical Committee approvals in alignment with global strategies.
Salary
Competitive remuneration; Annual incentive plan bonus; Healthcare and employee benefits
Skills & Requirements
Must-have
local regulatory submission preparation
Ethical Committee and MoH alignment
site start-up activity coordination
Nice-to-have
knowledge of gene therapy approvals
experience with viral safety dossiers
negotiation skills for grant budgets
Key Requirements
understanding of PPD SOPs and client directives
knowledge of current regulatory guidelines
ability to maintain accurate trial status databases