Regulatory Labeling Lead Katalyst HLS

Responsibilities: In support of these activities, the Provider will adhere to Client established timelines as indicated in SOPs, implementation guidelines, job aids, guidance documents, regulatory requirements, training materials and other related communications provided by Client. Reinforce labeling strategy by guiding and advising the Labeling Team on internal labeling guidance and policies and will raise awareness of important factors to consider when revising the label. Remain up-to-date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and advise the Labeling Team on the application of these labeling principles. Be knowledgeable on key labeling requirements worldwide. Ensure that downstream impact on CLDs is considered during Labeling Team discussions. Advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling te
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