Associate Director, Labelling Strategy
📋 Role Overview & Responsibilities
R&D Partners is seeking to hire a Labelling Strategy Associate Director in Gaithersburg, MD. Your main responsibilities as a Labelling Strategy Associate Director:· 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 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. What we are looking for in a Labelling Strategy Associate Director:· BS/MS Degree in Science or related discipline· 5+ years pharmaceutical experience, including regulatory experience, preferably working with labelling· Labelling expertise in Core Data Sheet, EU/US labelling experience, Ability to lead teams and labelling negotiations with Health authorities (e.g FDA, EMA).· Knowledge of labelling regulations and guidance· Excellent verbal and written communication skills
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This position is located in Gaithersburg, MD with potential relocation and sponsorship assistance depending on candidate qualifications.
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