Senior Regulatory Affairs Specialist

Job Summary

To support a growing clinical team, the full-time Senior Regulatory Affairs Specialist will manage regulatory submissions, oversee planning for IND-related activities, and represent Regulatory Affairs on cross-functional teams in a remote work environment.

Key responsibilities

• Manage the planning, compilation, quality control, and submission of INDs, BLAs, and their amendments
• Oversee submission planning for IND-related activities, including Annual Reports and DSURs
• Independently manage vendors and CROs to ensure timely and high-quality regulatory submissions

Required qualifications

• BS degree required; advanced degree (PharmD, PhD, Master's) preferred in pharmacy, chemistry, or biology
• Minimum 8 years of experience in regulatory affairs or related functions in drug/biologic development
• Familiarity with global health authority submissions in eCTD format is a plus
• Understanding of US and international regulations and ICH guidelines
• Advanced skills in Microsoft Office Suite and Adobe Acrobat Pro