Base: €60,000.00 - €80,000.00; bonus/equity: not s...
Hybrid
8+ years regulatory writing experience
Expert knowledge of ctd submissions
Clinical study report (csr) authoring
The role involves leading complex regulatory submissions and delivering high-quality clinical documents to support marketing authorization applications globally
Job Summary
The role involves leading complex regulatory submissions and delivering high-quality clinical documents to support marketing authorization applications globally.
Candidates must possess expert knowledge in global drug registration and the ability to work independently as a subject matter expert on clinical deliverables.
The position offers a competitive salary range of €60,000 to €80,000 with opportunities for hybrid work and participation in company benefit programs.
Matching Summary
The role involves leading complex regulatory submissions and delivering high-quality clinical documents to support marketing authorization applications globally.
Salary
Base: €60,000.00 - €80,000.00; Bonus/Equity: Not specified; Benefits: Eligible for Company employee benefit programs
Skills & Requirements
Must-have
8+ years regulatory writing experience
Expert knowledge of CTD submissions
Clinical Study Report (CSR) authoring
Periodic Benefit-Risk Evaluation Report (PBRER)
Risk Management Plan (RMP) development
Independent document delivery capability
Nice-to-have
Mentoring junior medical writers
Cross-therapeutic area agility
Stakeholder management skills
Vendor collaboration experience
Global team collaboration
Key Requirements
Minimum 8 years experience in pharmaceutical regulatory writing
Advanced degree in life sciences, pharmacy, or medicine