Senior Manager, Regulatory Affairs

Job Summary

Managing regulatory projects remotely, the full-time Senior Manager, Regulatory Affairs will oversee the planning and coordination of regulatory submissions, provide strategic guidance to cross-functional teams, and ensure compliance with regulatory requirements.

Key responsibilities

• Plan and manage regulatory activities for assigned projects, including clinical and non-clinical areas
• Develop and implement strategies for timely approvals of regulatory submissions
• Prepare, review, and submit regulatory dossiers, including INDs and NDAs, while maintaining compliance with regulations

Required qualifications

• 7+ years of related experience with a BA/BS degree
• Experience in the preparation of INDs and knowledge of NDAs
• Familiarity with CTD/eCTD and publishing documents in Adobe Acrobat Professional
• Working knowledge of FDA and ICH regulatory guidance
• Understanding of GMP, GLP, and GCP regulations, as well as the pharmaceutical product life cycle