- The Label Editor is accountable for the development, editing, approval, and control of pharmaceutical labeling manufactured in US/Puerto Rico regional plants and third party manufacturers.
- The position is also responsible for the creation and maintenance of labeling related specifications.
- The applicant must have the ability to assess the impact of a label change on other product labeling and manufacturing operations and assure compliance with FDA regulations and cGMP s.
- Manage and maintain labeling for assigned product lines. Initiate, prepare, review, approve and implement new or revised labeling.
- Assure label content meets corporate, Regulatory and FDA requirements.
- Have the ability to interpret governmental regulations and have a basic understanding of the requirements for pharmaceutical labeling.
- Evaluate the impact of a labeling change on associated labeling and manufacturing operations.
- Create label copy for new drug applications (NDA s) and ensure product filings have complete and accurate label content.
- Upon FDA approval, manage the flawless execution of approved labeling to meet operational goals.
- Review proposed changes to regulations, USP/NF or FDA Guidelines, and determine impact to labeling.
- Initiate and manage changes to assure compliance.
- Explore and implement continuous improvement opportunities that increase efficiencies and reduce cycle time.
- Communicate and negotiate label implementation with Regulatory Affairs and plant Operations.
- Participate on project teams representing Label Control for new product launches, labeling related projects, and/or new package designs.
- Ability to interpret governmental regulations and have a basic understanding of the requirements for pharmaceutical and animal health product labeling.
- Assist Marketing, as required, in the development of label designs for packaging commodities.
A-Line Staffing Solutions