Regulatory Consultant – CMC, Small Molecule Products

Role Overview

• Support the execution of multi-product global regulatory CMC for marketed products for small molecule products.
• Contribute to the preparation and submission of regulatory CMC documentation.
• Provide regulatory support to various cross functional teams.
• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on Middle East and North Africa.
• Review CMC sections of regulatory submissions and interactions with regulatory agencies for small molecule products.
• Work with regulatory colleagues in development of global regulatory CMC strategies and submissions.
• Participate effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

Requirements

• Support the execution of multi-product global regulatory CMC for marketed products for small molecule products.
• Contributes to the preparation and submission of regulatory CMC documentation.
• Provides regulatory support to various cross functional teams.
• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on Middle East and North Africa.
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies for small molecule products.
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions.

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.