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Associate II / Sr. Associate, Regulatory Labeling

Provides regulatory labeling support including QC of labeling documents, artwork QC, translations management, and labeling project coordination.

Perform quality checks in accordance with local labeling requirements (EU, US, and ROW).

Ensure regulatory compliance, accuracy, timely completion and version control of all new and revised text on labeling components.

Preparation, approval management, and distribution of product labels including drafting initial document to SPL approval.

Manage electronic and physical labeling repositories.

Perform continuous coordination, monitoring and expediting of labeling changes to meet established deadlines for submissions and implementation. Includes, maintaining and tracking project schedules, deliverables, timelines and activities and follow up with SMEs and project team members.

Provide input to internal tracking systems/databases to control workflow and ensure labeling projects/submissions and implementation deadlines are met.

Assist with regulatory research supporting labeling activities.

Support Product Labeling Leads in the maintenance of labeling regulatory / quality systems, and updating and managing electronic labeling files.

Communicate with labeling managers to ensure any new regulatory requirements are incorporated into the labeling documents.

Provide input to internal tracking systems/databases to control workflow and ensure labeling projects/submissions and implementation deadlines are met.

Work with Packaging Operations and Supply Chain to facilitate implementation of labeling for printed packaging components.

Review worldwide labeling against the Core Company Safety Information and with regard to business needs for accuracy and consistency of message.

Work with cross-functional stakeholders to support timely submission, approval, and distribution of product labeling with the strategies and objectives developed by the labeling teams

Receive and collate labeling text from labeling team members and put text into appropriate labels

Prepares communications for approved/effective product labeling to key stakeholders.

Prepare drug listing and establishment registrations for the US.

The candidate is expected to have a 2-4 years’ experience in Regulatory Affairs or equivalent experience. Working knowledge of FDA and EU GMP and labeling regulations/Guidance. Knowledge of International regulations a plus.

  • Have a passion for quality and an impeccable detail orientation
  • Strong planning and organizational / project / workload management skills
  • Thrive in, and be able to work in, a fast paced environment
  • Technology savvy: extensive experience in PC-Based word processing software, databases and spreadsheets, including Microsoft Office Word and Excel, Adobe Acrobat and MS Project
  • Familiarity with SPL, PLR, QRD templates and other formatting requirements
  • Solid interpersonal (verbal and written) communication skills at all levels (peers to executive management)

A four-year degree in life sciences (science degree preferred)

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