AD Regulatory Labelling Strategy
📋 Role Overview & Responsibilities
Details for the position are as follows:12-month contract to start. Rate: $65-71hrLocation: RemoteJob Description:Ensures that the labelling process is followed through the lifecycle of the product.Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.Leads the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.Leads the development of labelling negotiation strategies, anticipating HA perspectives.Provides labelling expertise for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigationsEvaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labellingEnsures appropriate communication across Labelling subfunctionsAble to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.Leads the development of target labelling documents as appropriateRequired Skills:Bachelor’s Degree required. Minimum 3 years of regulatory labeling experience.
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