Regulatory Affairs Specialist - Advertising and...Posted: November 15, 2009
Position Summary The Advertising and Promotion Specialist works with the Advertising and Promotion Senior Manager to review, approve, and monitor product advertising and promotional labeling pieces for compliance with Regulatory Authority requirements. Serves as the primary interface to the Regulatory Operations Specialist charged with completion of post marketing reporting requirements. Specific Job Duties ? Work with the Advertising and Promotion Senior Manager to make certain all Bausch & Lomb pharmaceutical advertising and promotional materials are in compliance with regulatory requirements and Bausch & Lomb policies ? Monitor DDMAC activity (e.g., letters, guidance, etc.) and assist the Senior Manager in completing an analysis of how such would apply to Bausch & Lomb ? Support the preparation and submission of launch packages for DDMAC comment where appropriate ? Monitor competitor ads to keep abreast of market promotional and advertising strategies ? Prepare routine reports and draft documents for Regulatory Authority communications Technical Competencies ? Knowledge of pharmaceutical industry regulatory affairs discipline ? Knowledge of laws, regulations, and guidance in relation to pharmaceutical products ? Knowledge of PhRMA Code, CHPA, and GMA codes as well as other regulations and guidance related to product promotion ? Knowledge of key enforcement activities and ability to assess the changing regulatory environment to determine impact to Bausch & Lombs pharmaceutical product line ? Detail-oriented with the ability to proofread and check documents for accuracy as well as the ability to relate information in review to requirements and to identify inconsistencies 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 ? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies ? Risk adverse where needed with the ability to identify potential solutions to complex problems Please refer to job code 750375 when responding to this ad.
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