Regulatory Affairs Senior Manager - LabelingPosted: November 15, 2009
Position Summary The Labeling Senior Manager provides regulatory oversight for all labeling issues for pharmaceutical products, which includes Brand, OTC/Nutritionals, and Generics. Monitors product labels for compliance with regulatory requirements. Serves as the primary interface with Regulatory Authorities for all labeling negotiations. Specific Job Duties ? Provide Regulatory support in the development, review, and approval of all labeling content for submission to Regulatory Authorities, as well as any post marketing labeling changes ? Review new labeling for accuracy and for other regulatory requirements ? Liaise with Global Regulatory Affairs Director and the product development teams to ensure the accuracy of all information included on the label or in the labeling ? Support the review process and coordinate with other Regulatory functions for the submission and approval of labeling content ? Develop and maintain tools/lists that support the coordination with other Bausch & Lomb functions (e.g., Quality, Manufacturing) to make certain only agency approved labels are produced for appropriate products ? Lead the development and maintenance of labeling core data sheets in accordance with Bausch & Lomb policies and procedures ? Work with the global regulatory counterparts to translate labeling into local languages ? Monitor changes to Reference Listed Drug (RLD) products ? Develop draft responses to Regulatory Authority letters regarding labeling ? Maintain, catalog, and retain all labeling materials in accordance with Bausch & Lomb policies and procedures ? Complete electronic drug listing for applicable drugs in accordance with federal requirements and guidance documents Technical Competencies ? Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations ? Knowledge of global regulations relating to submissions and regulatory approval of drug products ? Knowledge of pharmaceutical industry product labeling processes for review and obtaining regulatory approvals ? Strong general technology skills and abilities ? Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data Professional Competencies ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute and lead a team environment ? Ability to see the business drivers outside of Regulatory Affairs ? Excellent communication skills; both oral and written ? Strong interpersonal skills with the ability to influence others in a positive and effective manner ? Demonstrated ability to contribute to a continuous learning environment ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies Please refer to job code 750381 when responding to this ad.
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