Director - Regulatory Affairs Operations

2 days ago

🇺🇸 United States – Remote

💵 $194k - $244.3k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

Apply Now
Logo of PTC Therapeutics, Inc.

PTC Therapeutics, Inc.

Orphan and Ultra-orphan Disorders • Oncology • Anti-infectives

501 - 1000

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.

Apply Now

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