Senior Manager – Global Regulatory Device Labeling Strategy Lead

Senior Manager – Global Regulatory Device Labeling Strategy Lead

Requirements

• Minimum of 4-7 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.). Up to 3 years of direct experience in a global, US, or EU labeling role is desired. Experience in plasma-derived therapies and biologics preferred.
• Bachelor’s or Master’s degree required. Advanced scientific or health sciences degree or equivalent relevant experience preferred.
• Must have a detailed understanding of pharmaceutical drug and device development and global regulations pertaining to labeling, specifically, EU and US labeling requirements and guidance. Combination product/drug-device labeling knowledge is preferred. Advertising and promotion knowledge is a plus.
• Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
• Understanding of SPL format, requirements and guidance for legacy and PLR labels.
• Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.

Responsibilities

• Independently leads Labeling cross-functional teams, driving cross-functional collaboration and alignment of the labeling strategy and labeling content for the Information for Use (IFU) and key global labeling documents.
• Assists in the development of labeling strategies and content and to ensuring cross-functional alignment for other medium and/or high complexity products (including combination, Software as a Medical Device, and standalone medical device products).
• Manages labeling and device labeling strategies for the PDT BU via the development and lifecycle management of the IFU, CCDS, US, and EU labels.
• Authors new/revised IFU content for the TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functional areas with appropriate annotations and supporting documentation with appropriate supervision and guidance.
• Assists in the development of innovative regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
• Prepares strategic labeling vision for early development programs and gains alignment from internal stakeholders.
• Draws on labeling precedent, Health Authority feedback, and guidance, to create innovative labeling strategies.
• Provides guidance on combination product/drug-device labeling.
• With support of related functions interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.
• Develops creative solutions for data presentation and gains consensus by labeling teams to meet the requirements of the Health Authorities.
• Manages global labeling team and cross-functional projects.
• Manages IFU, CCDS, US, and EU Labeling Teams in the development and maintenance of labeling.
• Actively engages cross-functional labeling stakeholders to gain consensus on labeling strategy.
• Identifies and resolves conflicts/issues to reach labeling decisions including escalation to management for dispute resolution.
• Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to labeling and communicates the impact on the PDT BU products.
• Provides guidance to Regulatory affiliates as necessary in assessment of labeling changes to ensure timely implementation.

Preferred Qualifications

• Up to 3 years of direct experience in a global, US, or EU labeling role is desired.
• Experience in plasma-derived therapies and biologics preferred.
• Advanced scientific or health sciences degree or equivalent relevant experience preferred.
• Combination product/drug-device labeling knowledge is preferred.
• Advertising and promotion knowledge is a plus.