Senior Associate US Regulatory Affairs

Job Summary

To support regulatory projects, the full-time Senior Associate, US Regulatory Affairs will manage regulatory submissions, provide guidance on regulatory strategy, and ensure compliance with regulatory requirements while working remotely.

Key responsibilities

• Plan and manage regulatory activities related to assigned projects in clinical, non-clinical, and CMC areas
• Develop and implement strategies for timely approvals of regulatory submissions
• Prepare, review, and submit all components of regulatory submissions, including INDs, BLAs, and annual reports

Required qualifications

• BA/BS in Health Science with at least 2+ years of experience in the pharmaceutical industry
• Experience in the preparation of INDs and knowledge of NDAs and supportive amendments
• Familiarity with CTD/eCTD and experience with Adobe Acrobat Professional
• Understanding of FDA regulations and knowledge of GMP, GLP, and GCP regulations
• Detail-oriented, self-starter comfortable with broad responsibilities in a fast-paced environment