Regulatory Affairs - Labeling

Job Description

We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which provide instructions for the safe and effective use of products for patients and healthcare providers globally.

As part of the Labeling Operational Excellence function in Global Labeling, the Labeling Operations Specialist is responsible for:

Serving as the primary labeling operations point of contact for Global, US, and EU Labeling Leads

Receiving, reviewing, and processing labeling operational tasks for Core, US and EU labeling update requests on schedule, ensuring timely resolution of any issues throughout the update cycle while ensuring all labeling deliverables meet regulatory standards and timelines with consistent, high-quality execution

Performing labeling operational tasks (quality checks, verifications, proofreading, creation of labeling documents, including US SPL, and updating trackers)

Providing effective functional oversight in situations where a vendor performs labeling operational tasks

Collaborating with cross-functional teams to prioritize and manage labeling operational support for labeling updates, which may include product launches

Being Subject Matter Experts (SMEs) for labeling operational tasks and relevant business processes, systems, and documentation, including supporting process documentation updates

Monitoring and compiling competitor labeling for strategy development and decision‑making to Global, US and EU Labeling Leads

Required Experience & Skills:

At least 2 years’ experience in the pharmaceutical industry in operational roles, project management or regulatory affairs.

Excellent communication and organizational skills, with a proven ability to simultaneously balance diverse activities for several projects.

Good interpersonal skills.

Excellent attention to detail and quality-oriented