Qualifications
Summary of Job Description: The Regulatory Affairs TA Manager will ensure first-time approvals for new products and indications by collaborating with local brand teams.Key Responsibilities:Formulate local regulatory strategies and plans for major submissions to register New Chemical Entities (NCE) or new indications, coordinating with the Director of Regulatory Affairs and establishing local submission timelines.Lead strategic discussions to expedite development, engage with regulatory authorities, and prepare for early submissions based on developed strategies.Communicate Japan's submission requirements to the relevant regional and global regulatory teams.Assess local regulatory risks for submissions and devise mitigation strategies as necessary.Keep the TA team manager informed about regulatory affairs and new product information.
About the job
At AbbVie, we are dedicated to discovering and delivering innovative medicines and solutions that tackle significant health challenges today and prepare for the medical needs of tomorrow. Our impactful work spans several critical therapeutic areas, including immunology, oncology, neuroscience, and eye care, alongside our diverse Allergan Aesthetics portfolio.
As the Manager of the Regulatory Affairs TA for Oncology, you will play a pivotal role in ensuring the successful approval of new products and indications. Your contributions will be vital as you engage with local brand teams and regulatory authorities, driving strategies for timely submissions.
About AbbVie Inc.
AbbVie Inc. is committed to discovering and delivering innovative medicines that address serious health issues and future medical challenges. We aim to make a significant difference in people's lives across various therapeutic areas, including immunology, oncology, neuroscience, and eye care. Our portfolio also includes products and services from Allergan Aesthetics. For more details about our mission and values, visit www.abbvie.com.