Director Regulatory Labeling
My client is a mid-sized bio-pharmaceutical company worldwide; focused on developing treatment for rare diseases and illnesses. They are a financially stable organization with a deep pipeline of various therapies along with long-term opportunities to be a part of 10+ global filings over the next decade. They are currently looking for a Director/Senior Director Regulatory Labeling to manage the strategic aspects of Regulatory Labeling for CCDS. The ideal professional has well developed communication skills, the ability to manage others worldwide and will excel in this fast paced environment.
Responsibilities:
- Oversee the development of the US and EU label and the labeling process
- Manage and facilitate review of CCDS and regional labeling via the Labeling Team and Executive Labeling Committee (ELC)
- Identify and resolve conflicts/issues to reach labeling decisions
- Oversee the preparation of submission-ready labeling components; consults with affiliates on Health Authority communications regarding labeling
- Facilitate consensus among labeling teams and ELC and secure appropriate approvals on labeling decisions. Ensure stakeholder awareness of proposed and newly approved labeling changes
Knowledge and Skills:
- Bachelor’s degree in a scientific discipline or closely related field is required
- Minimum of 10 years of regulatory experience in the pharmaceutical/biotechnology industry
- Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling
- Expertise in developing Company Core Data Sheet required
- Knowledge of global guidance relevant to labeling, drug development, and commercialization of prescription medicines
- Excellent knowledge 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