Regulatory Affairs Labeling Compliance and Business Solutions Lead

Job Overview

This role involves partnering with labeling teams, stakeholders, and leadership to assess challenges and implement solutions in regulatory affairs labeling. It serves as the global process owner for electronic Instructions for Use (eIFU), managing the website solution, supporting business unit onboarding, ensuring compliance, and identifying opportunities. Additional responsibilities include developing and managing labeling software solutions, engaging with teams to improve systems and processes, and building internal communications networks.

Responsibilities

• Act as Global Process Owner for eIFU solution, identifying data risks, administering policies, and overseeing forums and meetings.
• Support labeling technology platforms, monitor onboarding, and participate in system enhancements.
• Develop expertise in labeling regulations to advise and support deliverables and initiatives.
• Own BD-wide labeling policies and procedures.
• Review systems and processes for optimization and alignment with requirements.
• Identify and evaluate new labeling technology solutions and lead projects for implementation.
• Review regulations impacting product labeling and facilitate updates to procedures.
• Communicate with stakeholders, monitor activities, and collaborate to resolve issues.
• Assess feedback, summarize impacts, and escalate risks or misalignments to leadership.

Qualifications

• Ability to socialize change to upstream and downstream stakeholders.
• Strong problem-solving skills for labeling processes.
• Experience in monitoring labeling metrics.
• Expertise in labeling regulations and processes.
• Skills in regulatory, quality, and business alignment.