Regulatory Affairs Labeling Lead
My client is a leading generic pharmaceutical company focused on delivering medicines for cardiovascular diseases, oncology, metabolic diseases, anti-infective, infusion and pain management. They are looking for a Regulatory Labeling Lead to join the team, reporting 3 days per week onsite in East Brunswick, New Jersey.
The Regulatory Affairs Labeling Lead will be responsible for:
- Preparing, reviewing, and approving pharmaceutical labeling for generic drug products including container labels, cartons, package insert, medication guides, etc.
- Creating draft labeling for new generic drugs for submission in ANDAs to the FDA.
- Ensuring labeling meets FDA requirements and internal timelines.
The Regulatory Affairs Labeling Lead should have the following qualifications:
- 2+ years Regulatory Affairs Labeling experience.
- Generic drug labeling experience required.
- Knowledgeable in FDA Labeling requirements