AstraZeneca Pharmaceuticals LP
TITLE: Global Labeling Strategy Manager (Gaithersburg, MD, Mon-Fri, 40 hrs/weel)
DUTIES: Provide regulatory labeling expertise to the Global Regulatory Submission Team (GRST), Global Regulatory Execution Team (GRET) and cross functional Product Labeling teams, with guidance from the Global Labeling Director. Contribute to the development of the labeling strategy and lead the maintenance and implementation of Core Product Information and United States (US) and European Union (EU) Market Product Information (MPI) for assigned company market or pipeline products. Ensure the labeling process is followed throughout the lifecycle of the product. Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs. Contribute to the development of the labeling strategy, in line with overall regulatory strategy for the product. Apply knowledge and understanding of labeling regulations, guidance and competitor analyses. Contribute to the development of labeling negotiation strategies, anticipating health authority perspectives. Evaluate, interpret and communicate global regulations and trends on labeling and business impacts these have on product labeling. Lead the Product Labeling Team in preparation and maintenance of high quality Core Prescribing Information, EU Quality Review of Documents (QRD), US Prescribing Information (PI), and Instructions For Use (IFUs) to Senior Leaders for approval to achieve advantageous labeling. Provide guidance regarding applicable labeling requirements and expectations to relevant stakeholders, including risk insight and proposing mitigations. Develop labeling policies, procedures and SOPs.
REQUIREMENTS: Must have a Master's degree or a foreign equivalent in Life Science, Pharmacy, Regulatory Affairs or a related field, plus three (3) years of experience in the job offered, or as a Global Labeling Operations Manager, Regulatory Affairs Associate or a related position. Employer will accept pre-or-post Master's degree experience. Must have three (3) years of experience with: pharmaceutical project management; supporting local marketing companies; product lifecycle management; knowledge of US and EU pharmaceutical labeling regulations and guidelines; product development; post-approval regulatory labeling processes including variations and line extensions; eCTD submissions; and Document Management Systems.
Click apply. No calls please. EOE.
Valid through: 11/20/2020