Regulatory Labeling Expert
We are seeking a skilled Regulatory Labeling Expert to join our team. In this role, you will play a crucial part in developing and implementing global regulatory labeling strategies for our diverse portfolio.
Main Responsibilities:
* Develop, implement, and maintain global regulatory labeling strategies, implementation plans, and input to risk management plans to support successful registration and lifecycle management with desired labeling.
* Lead the development of Target Product Labels (TPL), Core Documents such as Company Core Data Sheets (CCDS), US Package Insert (US PI), and European Summary of Product Characteristics (EU Sm PC) in alignment with Global Regulatory Strategy.
* Conduct detailed competitive intelligence labeling analysis for approved and development products to inform and optimize program labeling strategies.
* Collaborate with regulatory project teams and cross-functional teams, including market access, commercial, clinical, safety, and compliance colleagues, to align regulatory labeling initiatives with Target Product Profiles.
Requirements:
* Minimum of 7+ years of relevant experience, including the development and implementation of at least one successful global regulatory labeling strategy for a commercialized product.
* Strong knowledge of drug development and regulatory intelligence, coupled by excellent scientific and business judgment.
* Ability to manage complex issues and timely coordinate multiple projects simultaneously.
* Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.
Benefits:
* A unique blend of entrepreneurial spirit and global resources allows us to continuously push boundaries in research and development.
* An energizing culture that fosters collaboration, creativity, and personal growth.
* Tailored development programs that align with our mission to improve patient outcomes.