PTC Therapeutics, Inc.
Orphan and Ultra-orphan Disorders • Oncology • Anti-infectives
501 - 1000 employees
Founded 1998
Director - Regulatory Affairs Operations
November 12
PTC Therapeutics, Inc.
Orphan and Ultra-orphan Disorders • Oncology • Anti-infectives
501 - 1000 employees
Founded 1998
Description
• Lead the regulatory information management program globally. • Drive meaningful changes to support RIM goals. • Collaborate with Global Regulatory Affairs to refine global processes. • Ensure compliance with health authority requirements including FDA and EMA.
Requirements
• Bachelor’s degree in a scientific or technical discipline. • Minimum of 10 years of relevant Regulatory Affairs professional experience. • Knowledge and/or awareness of GCP/GLP/GPvP/GDP regulations. • Extensive knowledge of regulatory requirements for computerized systems (21 CFR Part 11). • Good understanding of drug development processes; clinical, non-clinical, pharmacovigilance. • Strong knowledge and expertise in audit fundamentals and managing audit programs.
Benefits
• Short- and long-term incentives. • Eligible for medical, dental, vision, and retirement savings plans.
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