Regulatory Affairs Associate I

Key Responsibilities

• Support regulatory information management activities using internal regulatory systems.
• Create, update, and maintain product registration and regulatory records.
• Track regulatory submissions, approvals, renewals, and agency correspondence.
• Maintain accurate regulatory documentation and commitment records.
• Ensure data integrity and compliance across regulatory databases.
• Afford assistance with audit and inspection requests.
• Support quality control reviews and data remediation activities.
• Collaborate with regulatory, data management, and cross-functional teams.
• Participate in process improvements and system enhancement initiatives.

Required Qualifications

• Bachelor's Degree in Pharmacy, Biology, Chemistry, Pharmacology, Medical Technology, or related Life Sciences field.
• Recent graduate or early-career professional with a life sciences background.
• Strong written and verbal communication skills.
• Excellent attention to detail and organizational abilities.
• Proficiency in Microsoft Office applications.