Manager, Regulatory Affairs
The Regulatory Labeling Manager is a tactical and strategic role within Global Branded Products Regulatory Affairs (GBP RA) and is generally responsible for creating labeling documents in support of regulatory submissions, managing labeling artwork creation, tracking labeling implementation, completing structured product labeling and drug listing submissions, and creating labeling sections of routine reports (PADER, Annual Report). The manager will support the regulatory strategy teams in scheduling and managing internal Teva labeling committees for products in the Respiratory, Oncology and Women’s Health therapeutic areas.
Essential Duties and Responsibilities:
- Labeling Content Development: Manages the creation process for labeling content (Product Working Group) for submissions (labeling supplements, Annual Reportable Changes). Creates labeling submission documents (word, pdf, artwork files, and Structured Product Labeling).
- Labeling Implementation: Manages implementation of new and revised labeling. Creates and distributes mark-up labeling documents and artwork requests, works with artwork management team to create and approve artwork for labeling components, tracks implementation activities. Reviews and approves labeling components in Veeva. Maintains current and historical labeling activity history files (SharePoint and EDMS-based). Maintains the US Labeling Repository SharePoint site.
- Periodic Reporting: Completes labeling sections for periodic reporting (PADERs and Annual Reports). Supplies current labeling components for reports.
- Structured Product Labeling: Creates, updates and submits Structured Product Labeling (SPL) content of labeling and drug listing files for marketed products and regulatory applications. Ensures labeling content and drug listing data elements are maintained as current for marketed products.
- Supports process improvements within the labeling function (labeling history tracking tool, document storage consolidation).
- Follows Teva Safety, Health, and Environmental policies and procedures.
- Develops labeling content for labeling submissions prescriber labeling, patient labeling, carton and container labeling, and manages subsequent submissions (labeling supplements, Annual Reports, PADERs). Documentation of the process and actions are maintained according to procedures.
- Initiate and track to completion all labeling implementation activities. Maintain structured product labeling for branded products. Maintain labeling history records.
- Bachelor’s degree in scientific field of study such as Biology, Chemistry or other related life science
- 5+ years of experience working in pharmaceutical industry with 4+ years of experience in regulatory affairs and/or regulatory labeling
- Advanced training in science, regulatory affairs and/or drug development
- 7+ years of pharmaceutical industry experience with at least 5+ years of experience in regulatory affairs with increasing level of responsibility and experience in drug product labeling, strategy and submissions
- Working knowledge of drug product development process, FDA regulations, directives and guidance for drug product labeling
Director Regulatory Affairs Labeling
If you are a current Teva employee, please apply using the internal career site available on “Employee Central”. By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Job posted: 2020-05-14