Regulatory Labeling Specialist Jobs in Massachusetts

Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE, novoGlow, etc.).

Ensures that all regulatory labeling items and information is appropriately tracked, archived, searchable and accessible.

Works directly with Regulatory Project Mangers to prepare labeling items consistent with content project plans.

Strong relationship management, analytical, and interpersonal skills required to quickly gain confidence of stakeholders and team members required.

Strong organizational skills enabling the management of multiple, simultaneous submissions often with different team members and different timelines.

Formal project management training optimal; practical project management skills and recent application required.

Manages communications and activities with third-party publishers and regulatory vendors.

Manages and indexes archives of regulatory submissions; manages and files regulatory correspondence.

Familiarity with Veeva Vault – RIM, Sharepoint, and publishing software strongly preferred. Sophisticated MS-Office skills required.