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Regulatory Affairs Labeling Associate

Company: Torrent Pharma Inc.
Location: Basking Ridge
Posted on: January 15, 2022

Job Description:

*This role is fully onsite 5 days/week in our Basking Ridge, NJ office

- Coordinate labeling projects to ensure regulatory compliance
- Provide guidance to team members on labeling regulations and process requirements
- Carry out project deliverables such as initiating, reviewing and implementing label creation/updates with extreme attention to detail
- Provide regular updates regarding labeling projects to cross functional departments to facilitate coordination for project completion timelines
- Forge relationships with thought leaders in their respective departments to enhance understanding of process needs
- Participation in project management meetings as the Clinical Development Operations representative
- Responsible for the creation of pharmaceutical labeling drafts/Final for submission to FDA based on Reference Listed Drug labeling, FDA requirements and Client requirements.
- Responsible for the creation of labeling in SPL ( X-forms) and PLR/PLLR format.
- Responsible for working with outside vendors for creation of labeling proofs and ensuring accuracy of final labeling.
- Responsible for managing and tracking the review process for labeling pieces to ensure timely submissions to FDA
- Responsible for identifying changes needed for FDA approved labeling including updates to Reference Listed Drug, USP updates and updates for new Regulatory requirements.
- Responsible for maintenance of all labeling files in accordance with internal procedures

Position Requirements
- Ability to function well under pressure and balance multiple projects
- Dedicated, detail-oriented focus in project initiation and review
- Skills in project management concepts and software
- Must have ability to take and follow directions. Familiarity with FDA Labeling guidelines (21 CFR) required.
- Must possess excellent communication and organizational skills, be a team player and flexible to work as per the priority
- Bachelor's degree or equivalent experience
- Proficiency with Microsoft Office programs, including but not limited to Word, Excel, PowerPoint and Outlook
- Knowledge of global medical device labeling requirements
- Experience with translation activities

Torrent Pharma Inc is an Equal Opportunity Employer.

Keywords: Torrent Pharma Inc., Newark , Regulatory Affairs Labeling Associate, Other , Basking Ridge, New Jersey

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