This client is an established global specialty biopharmaceutical company focused on treating rare diseases, with products available in more than 100 countries. They are seeking a Regulatory Labeling Strategy Team Lead to provide regulatory expertise and guidance to internal stakeholders for successful development of Company Core Data Sheets and global labeling. You will formulate regulatory labeling strategies for implementation of new and revised prescribing information and packaging while providing expert advice on current labeling requirements, templates, and tools.
Responsibilities:
- Oversee the development of the US and EU labeling and the labeling process
- Formulate and implement regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products
- Manage and facilitate review of CCDSs and regional labeling via the Labeling Team and Executive Labeling Committee.
- Facilitate consensus among labeling teams and Executive Labeling Committee and secure appropriate approvals on labeling decisions.
- Ensure stakeholder awareness of proposed and newly approved labeling changes
- Identify and resolve conflicts/issues to reach labeling decisions
- Communicate CCDS updates and timelines for submission of revisions to Health Authorities
- Ensure compliant version control of product labeling and other related documentation
- Assess resources necessary to properly support US and EU labeling
- Interpret scientific and clinical data and lead development of labeling to optimize product potential and patient benefit-risk ratio.
- Maintain awareness of regulatory legislation pertaining to labeling, assessing and communicating impact on business and products.
- Prepare final proposed labeling for review by the Labeling Team and Executive Labeling Committee prior to internal approval and/or submission to health authorities.
- Oversees the preparation of submission-ready labeling components; consults with affiliates on Health Authority communications regarding labeling
- Mentor employees/consultants
- Interview, hire and train employees/consultants
Qualifications:
- Bachelor’s degree in a scientific discipline or closely related field is required
- Minimum of 10-12 years of regulatory experience in the pharmaceutical/biotechnology industry with eight or more years in Labeling
- Must have a detailed understanding of pharmaceutical drug development and global regulations pertaining to labeling
- Expertise in developing Company Core Data Sheet
- 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
- Ability to communicate and resolve issues during labeling reviews and conversations.
- Understanding of SPL format, 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
- Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
- Excellent analytical, technical and problem-solving skills.
- A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach.
- Demonstrated leadership ability.
- Ability to manage complex projects and timelines in a matrix team environment.
- Strong attention to detail and accuracy.
- Ability to present information effectively to senior management, regulatory authorities, public groups and other departments.