Global Labelling Manager

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. There are two main drivers of innovation that are the focus of the PDT R&D organization:
Translational Pharmaceutical Sciences and Precision Medicine

• The Global Regulatory Labelling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labelling and works under the direction of the Head of Global Labelling and is:
• Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific,
• Commercial, to ensure successful development and maintenance of Labelling managed within
• PDT BU’s Global Labelling function, pertaining to pharmaceutical drug and device.
• Ensuring that there is strategic Labelling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans.
• Formulating regulatory Labelling strategies for implementation of new and revised prescribing information and packaging; strategically interprets scientific, medical, and regulatory data and information.
• Providing expert advice on current Labelling requirements, templates, tools, and Health Authority-issued guidance pertaining to pharmaceutical drug and device.

• Drives Labelling strategy for the PDT BU via the development and lifecycle management of the CCDS, US, and EU labels.
• Formulates and implements innovative regulatory strategies for Labelling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
• Prepares strategic Labelling vision for early development programs and gains alignment from internal stakeholders.
• Draws on Labelling precedent, Health Authority feedback, and guidance, to create innovative Labelling strategies.
• Provides guidance on combination product/drug-device Labelling.
• Interprets scientific and clinical data and leads development of Labelling to optimize product potential and patient benefit-risk ratio.
• Introduces creative solutions for data presentation and gains consensus by Labelling teams to meet the requirements of the Health Authorities
• Prepares backup strategies in support of Labelling negotiations.
• Takes initiative in leading global Labelling team and cross-functional projects.
• Leads CCDS, US, and EU Labelling Teams in the development and maintenance of Labelling.
• Actively engages cross-functional Labelling stakeholders to gain consensus on Labelling strategy.
• Effectively identifies and resolves conflicts/issues to reach Labelling decisions with minimal escalation to management for dispute resolution.
• Liaises with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to Labelling and communicates the impact on the PDT BU products.
• Provides guidance to Regulatory affiliates as necessary in assessment of Labelling changes to ensure timely implementation.

• In close collaboration with the Client R&D Labelling function, oversees the direction, management and implementation of the Labelling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory Labelling guidance.
• Project manages new or updated Labelling to ensure compliance with internal procedural or Health Authority submission timelines.
• Manages and facilitates review of CCDSs and regional Labelling, as appropriate, via the Labelling Team and executive governance committees for PDT BU products.
• Prepares final proposed Labelling for review by the Labelling Team and approval by the executive governance committees, as appropriate, prior to internal approval and/or submission to health authorities.
• Manages the preparation of submission-ready Labelling components, consults with affiliates on Health Authority communications regarding Labelling.
• Ensures internal and external stakeholder awareness of proposed and newly approved Labelling changes, as required.
• Ensures compliant version control of product Labelling and other related documentation within the Client document management systems.
• Ensures QC of CCDSs and other Labelling documents.
• Updates Labelling decision records to ensure Labelling history is appropriately tracked and archived.
• Ensures…