Director, Regulatory Affairs (Labeling)

Responsibilities

• Collaborate cross-functionally to develop labeling strategy and lead cross-functional Labeling meetings.
• Manage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements.
• Maintain expertise regarding key labeling requirements and stay current with labeling guidelines/regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles.
• Research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.
• Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
• Liaise with cross functional members and stakeholders to obtain input pertaining to labeling including resolution of key regulatory issues and labeling changes.
• Partner with Clinical Regulatory and cross-functional teams to support labeling supplements and updates, and health authority interactions related to labeling.
• Ensure the dissemination of approved labeling documents and supporting documentation.
• Maintain controlled records for all labeling changes and communicate labeling updates to stakeholders at the time of implementation.
• Build partnerships with key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
• Participate in any relevant continuous improvement efforts for the end-to-end labeling process.
• Monitor global regulatory environment and assess impact of changes on business and product labeling activities.
• Facilitate policy development and updates with internal stakeholders.

Requirements

• Bachelor’s degree in life sciences, computer science, or related science discipline
• Minimum 8+ years in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas
• Knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
• Experience leading cross-functional meetings and facilitating strategic discussions, such as negotiating with internal stakeholders and regulatory authorities on complex labeling issues
• Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deviations and inconsistencies
• Strong knowledge of document formatting (MS Word documents, PDFs compliance, and validation tools)
• Ability to maintain highest degree of professionalism, integrity and diplomacy