Job scopes

• Define and develop regulatory filing strategies of assigned projects regarding approved products. This includes coordinating activities and defining content and timing of submission and approval in order to have global regulatory agreement, as required, before implementation.
• Provide regulatory assessments for proposed business and manufacturing changes related to approved products in compliance with guidelines and regulations
• Provide regulatory leadership during manufacturing site inspections.
• Utilize company approved tools and systems to manage regulatory issues, including enterprise system and regulatory/SDS authoring and label creation software.
• Review, advise and help prepare domestic and international labels, package inserts, etc. based on applicable regulations and approved platform labels, in cooperation with Business Operations, and Supply Chain.
• Serve as a member of interdepartmental working groups providing regulatory expertise for assigned projects or segments of projects related to approved products.
• Maintain an awareness of regulatory issues and current possible developments in assigned geographic and technical areas.
• Assist in the development and implementation of regulatory strategies necessary to: (1) optimize the position of the company's products in the market by regulatory means; (2) implement manufacturing strategies; and, (3) maintain the products throughout the lifecycle in line with company direction and agreed priorities including routine regulatory activities and taking into account the possible future evolution of the regulatory environment.
• Serve as regional point of contact as regulatory strategies are developed and implemented in order to achieve business and manufacturing strategies while accounting for regulatory threats, opportunities, constraints, and future changes.
• Ensure regulatory compliance of licensed products throughout their lifecycle, ensuring proper regulatory management of changes, deviations, exemptions, notifications, etc. in close collaboration with Operations, Quality Assurance, R&D, Business Operations, and others.
• Prepare core regulatory documents for product renewals, variations, country extensions, etc.,

Cristina Malabuyoc Malijan EA License No. 02C3423 Personnel Registration No. R1111547

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