Regulatory Affairs Manager

Job Summary

A company is looking for a Manager, Regulatory Affairs.

Key Responsibilities

• Plan and manage regulatory activities for assigned projects across technical areas
• Develop and implement strategies for timely approvals of regulatory submissions
• Prepare, review, and submit regulatory dossiers, ensuring compliance with regulatory requirements

Required Qualifications

• 5+ years of related experience with a Bachelor's Degree
• Experience in preparation of INDs and knowledge of NDAs
• Familiarity with CTD/eCTD and document publishing in Adobe Acrobat Professional
• Working knowledge of FDA and ICH regulatory guidance and regulations
• Understanding of GMP, GLP, and GCP regulations and the pharmaceutical product life cycle