Director, Regulatory Affairs
6 days ago
Description
• Manage and develop talent; may train/mentor junior staff. • Manage regional regulatory activities as part of a Global Regulatory Team. • Leads regulatory activities for assigned project(s). • Plans, coordinates, authors, and prepares regulatory submissions. • Leads regional health authority meetings. • Ensure compliance with global regulatory requirements.
Requirements
• 8 – 12 years of relevant experience in biotech or pharmaceutical industry. • Minimum of 8 years focused in regulatory affairs. • Master’s degree required (preferably in a scientific discipline). • Experience contributing to electronic regulatory submissions. • Experience interacting with the FDA and ex-US Health Authorities. • Proven success/major involvement in NDA/MAA/CTD submissions and approval.
Benefits
• Merit-based salary increases. • Short incentive plan participation. • Eligibility for the 401(k) plan. • Medical, dental, vision, life, and disability insurances. • Unlimited paid time off. • 11 paid holidays. • 80 hours of paid sick time.
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