Regulatory Affairs Analyst

Responsible for performing all duties in compliance with FDA’s Quality System Regulation (QSR), ISO13485, MDD, and all other international regulatory requirements. Prepare regulatory submission documents for new products or changes to existing health authorities' filings. Prepare new product notifications, CE Mark Technical Files/Dossiers, Investigational Device Exemptions and international regulatory submissions in various countries. Partners with various teams throughout organization (Marketing, Promotions, Operations, R&D, Quality, etc.) on projects. Assists with the management and execution process for global registrations and product life cycle management including generate product catalog and localization of labeling.

According to JobzMall, the average salary range for a Regulatory Affairs Analyst in Pleasanton, CA 94566, USA is $80,000 to $110,000 per year. This salary range is based on the experience and qualifications of the individual analyst.

Allergan plc is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. We are focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world. Allergan is now part of AbbVie. As one company, we have brought together over 30 brands and leadership positions, expanding and diversifying our product portfolio.