about 1 year ago
Director Level Regulatory Labeling Strategy Team Lead
Will provide regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP).You will ensure that there is labeling input in the implementation of regulatory strategies and liaise with regulatory team members in evolving submission and negotiation plans, and formulate regulatory labeling strategies for implementation of new and revised prescribing information and packaging. You must be able to provide expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidances.
- Bachelor’s degree in a scientific discipline or closely related field is preferred.
- 5 -8 years of regulatory or related experience in the pharmaceutical/ biotechnology industry.
- 2-4 years of direct experience desired
- A detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling.
- Expertise in developing company core data sheet.
- Knowledge of global guidances relevant to labeling, drug development, and commercialization of prescription medicines.
- Understanding of EU and US labeling requirements and guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and conversations.
- Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation.
Please submit your resume as soon as possible if you're interested in applying and hearing more information.