Regulatory Affairs Senior Specialist - OTC/NutritionalsPosted: November 15, 2009
Position Summary The Global Regulatory Affairs Senior Specialist handles activity for developing pharmaceutical regulatory strategies, submissions, and managing interactions with the regulatory agencies for OTC/Nutritional products. Specific Job Duties ? Provide support for the execution of the global product regulatory strategy for OTC/Nutritional pharmaceutical products ? Support regulatory aspects of product development team for agency filing ? Work with Regulatory Affairs Senior Manager for OTC/Nutritionals to make certain all product documentation is developed in accordance with regulatory requirements; serve as designee as needed ? Support the preparation of documentation and materials required for meetings with Regulatory Affairs for assigned products ? Liaise with country specific Regulatory Affairs personnel for international submissions and registrations ? Work with Labeling Senior Manager to make certain that all labels and labeling are accurate 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 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 750371 when responding to this ad.
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