Regulatory Affairs Senior Specialist - BrandPosted: October 27, 2009
Position Summary The Global Regulatory Affairs Senior Specialist executes on the pharmaceutical regulatory strategies for assigned brand products. Supports the Regulatory Affairs Senior Manager for Brand submission timelines and liaises with the country specific regulatory personnel for timely and accurate sharing of information to support compliance. Specific Job Duties: * Provide support for the execution of the pharmaceutical regulatory brand strategy for assigned products * Support regulatory aspects of product development team for agency filing * Work with the Pharmaceutical Regulatory Brand Senior Manager to make certain all product documentation is developed in accordance with regulatory requirements; serves as designee as needed * Support the preparation of documentation and materials required for meetings with Regulatory Authorities for assigned brand products * Liaise with country-specific regulatory affairs personnel for international submissions and registrations Technical Competencies: * Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations * Knowledge of domestic and international regulations laws, regulations, and guidance * Knowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization * Ability to partner within regulatory and with cross-functional teams in a global pharmaceutical organization * Ability to understand scientific information and assess whether technical arguments are articulated clearly * Ability to assess project risks and where appropriate, escalate accordingly Professional Competencies: * Demonstrated ability in analytical reasoning and critical thinking skills * Strong capability to contribute to a team environment * Strong business acumen and 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 and process improvement environment * Capacity to react quickly and decisively in unexpected situations * Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies * Focused ability to influence operational excellence and performance metrics * Risk adverse where needed with the ability to identify potential solutions to complex problems Please refer to job code 750341 when responding to this ad.
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