Regulatory Labeling Specialist Jobs

MUST HAVES:

1) LABELING DEVELOPMENT

2) SPL PREPARATION AND SUBMISSION

3) STRONG TECHNICAL KNOWLEDGE OF SYSTEMS/SOFTWARE: LIFT, ALiCE, Veeva Vault, TVT,

4. Experience and/or Familiarity with Structured Content is preferred

PURPOSE

The Labeling Specialist, supports the development of labeling activities for all regulatory submissions. This individual collaborates cross-functionally and applies skills and knowledge of drug development and how it relates to labeling operations and requirements to manage the execution of final packaging materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved submitted and maintained for use.

The Labeling Specialist, is also responsible for maintaining product and establishment registrations (drug/establishment listings) and submission to FDA databases. This individual acts as the Subject Mater Expert (SME) for electronic reports that are FDA compliant and with the required format (e.g., Structured Product Labeling (SPL), Lot Distribution Data (LDD), etc) and that is in alignment with the regulatory strategy.

This individual works cross-functionally with internal and external departments on Regulatory Affairs labeling related issues.

RELATIONSHIPS

Reports to labeling management in Regulatory Operations and Innovation.

Develop and maintain positive rapport and working relationships with company stakeholders.

Effective collaboration with Regulatory Affairs, CMR, Supply Chain, and HQ colleagues regarding labeling compliance to accomplish company goals.

External relationships may include interaction with FDA personnel, IT vendors and HQ colleagues regarding assigned projects and roles.

ESSENTIAL FUNCTIONS

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•Participates on cross-functional teams focused on the planning and execution of regulatory labeling operations. This includes anticipating labeling obstacles, identifying emerging issues and proactively developing solutions.

•May participate in FDA submission planning meetings to ensure clear communication of the project plan, actions items, risks, and decisions to the team as it relates to labeling operation processes.

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

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

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

•Participates locally and globally in initiatives focused on the improvement of regulatory labeling processes and tools (LIFT, Veeva Vaults, TVT, ALiCE, etc.). This includes contributing to new regulatory processes and providing training support as appropriate.

• Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support regulatory labeling-related activities. Updates internal processes to ensure compliance with health authority requirements and expectation.

QUALIFICATIONS

•A Bachelors degree required and minimum 4 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education required with a concentration in labeling development and maintenance.

•Demonstrated ability to work cross-functionally to develop project plans; proactively identify risks; develop risk mitigation strategies; communicate project team decisions and project status.

•Demonstrated ability and knowledge to participate in process/system improvements related to labeling and product/establishment registrations (LIFT, Veeva Vaults RIM, Registrations, and SPL).

•May be responsible for managing projects, processes, or programs with manager oversight.

Experience and/or Familiarity with Structured Content is preferred

•Knowledge of FDA and Health Canada eCTD submissions lifecycle management and associated guidance’s/specifications/regulations.

•Proficiency with Microsoft Office, Veeva Vault, TVT, ALiCE, LIFT, and other labeling systems

•Excellent verbal and written communication and skills.

•Ability to work independently and collaboratively, in a fast-paced environment consisting of local and global team members.