My client is an established global specialty biopharmaceutical company focused on treating rare diseases. They are seeking a Regulatory Labeling Strategy Lead to provide global labeling strategy guidance for orphan drug development programs and approved products. You will formulate labeling strategies and develop Company Core Data Sheets while providing expert advice on labeling requirements, processes, and tools. Now is the time to join this growing company and advance your labeling career!
Responsibilities:
- Drive the development of the label and the labeling process.
- Formulate and implement regulatory strategy for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products.
- Manage and facilitate review of CCDS and regional labeling via the Labeling Team.
- Develop Target Product Profiles for early stage development programs.
- Facilitate consensus among labeling teams and secure appropriate approvals on labeling decisions.
- Ensure stakeholder awareness of proposed and newly approved labeling changes.
- Drive the implementation of the labeling process; develop labeling templates, tools and systems to improve efficiency, consistency and compliance.
- Communicate CCDS updates and time lines for submission of revisions to Health Authorities.
- Manage labeling logistics including version control of product labeling and other related documentation.
- Ensure QC of CCDSs and other labeling documents; update labeling decision records to ensure labeling history is appropriately tracked.
- Maintain awareness of regulatory legislation pertaining to labeling, assessing and communicating impact on company’s business and products.
Knowledge and Skills:
- Bachelor’s degree in a scientific discipline or closely related field is required.
- Minimum of 7-9 years of regulatory experience in the pharmaceutical/biotechnology industry with five+ years in labeling development for branded prescription products.
- Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling.
- Expertise in developing CCDSs and Target Product Profiles.
- Knowledge of global guidances relevant to labeling, drug development, and commercialization of prescription medicines.
- Expertise in EU and US labeling requirements/ guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and discussions.
- Understanding of SPL formats, requirements and guidance for legacy and PLR labels. Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation