Regulatory Specialist - Core Diagnostics

Responsibilities

• Direct the development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports
• Interact with regulatory agencies to expedite the approval of pending registrations
• Serve as a regulatory liaison throughout the entire product lifecycle
• Participate in product plan development, regulatory strategy, risk management, and chemistry manufacturing control (CMC)
• Ensure timely approval of new drugs, biologics, or medical devices and maintain continued approval of marketed products
• Act as a regulatory representative to marketing and research teams
• Advise development and marketing teams on manufacturing changes, line extensions, technical labeling, and regulatory interpretations

Requirements

• Subject matter expertise in Regulatory Affairs
• Proven experience with product registration submissions
• Demonstrated ability to manage interactions with regulatory agencies
• Knowledge of CMC (Chemistry, Manufacturing, and Control) and risk management processes

About the Company

Abbott is a global healthcare leader that has been helping people reach their potential for more than 135 years. With a network serving customers in over 160 countries, we create innovative solutions across diagnostics, medical devices, nutrition, and branded generic medicines to help people live their best lives through better health.