Regulatory Affairs Associate Director - OTC/NutritionalsPosted: October 27, 2009
The Global Regulatory Associate Director handles all regulatory development aspects for OTC/Nutritional Pharmaceutical (• OTC/Nutritional?) products. Participates on the product development team to provide Regulatory guidance for OTC/Nutritional products. Manages relevant regulatory strategy components and interactions with the Regulatory Authorities for OTC/Nutritional products. May perform due diligence efforts on new product opportunities. Specific Job Duties: ? Responsible for developing a global product regulatory strategy for OTC/Nutritional pharmaceutical products ? Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development ? Develop a product regulatory timeline aligned to Bausch & Lombs product development strategies, with key regulatory milestones and activities for agency filing and labeling ? Liaise with product development teams in building awareness of Regulatory Authority requirements and timing for submissions and labeling content (as appropriate) ? Participate as a member of the product development team to make certain all product documentation is developed in accordance to regulatory requirements, including OTC Monograph and DSHEA standards ? Actively participate with commercialization teams with OTC innovation and discussion efforts ? Provide guidance to OTC switch opportunities ? Act as day-to-day regulatory contact with Regulatory Authorities for assigned pharmaceutical products (only with Review Divisions) ? Liaise with country-specific Regulatory Affairs personnel for international submissions and registrations ? Support and coordinate with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections ? Provide regulatory guidance/input to internal product review boards ? Manage assigned personnel Technical Competencies: ? Knowledge of Monograph and DSHEA standards ? Knowledge of OTC/Nutritionals industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations ? Knowledge of domestic and international laws, regulations, and guidance that affect OTC/Nutritionals products ? Knowledge of development milestones required for meeting authorizations for dietary supplement ? Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for OTC/Nutritionals products ? Ability to influence and partner with cross-functional teams in a global pharmaceutical organization ? Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data ? Ability to assess project risks, and where appropriate, recommend contingency plans, and strategies to mitigate regulatory risks Professional Competencies: ? Demonstrated ability in analytical reasoning and critical thinking skills ? Strong capability to contribute and lead 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 753804 when responding to this ad.
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