Regulatory Affairs Associate Director - GenericsPosted: November 15, 2009
Position Summary The Global Regulatory Affairs Senior Manager handles all regulatory development aspects for prescription generic pharmaceutical (• Generic?) products. Participates on the product development team for Regulatory guidance for Generic products. Manages relevant regulatory strategy components and interactions with Regulatory Authorities for Generic products. May perform due diligence efforts on new product opportunities. Specific Job Duties ? Responsible for developing a global product regulatory strategy for assigned Generic Pharmaceutical products ? Liaise with global regulatory counterparts to ensure regional requirements are incorporated into generic product approval ? Develop a product regulatory timeline aligned to Bausch & Lombs strategic goals in alignment with commercialization strategy with key regulatory milestones and activities for agency filing ? Participate as a member of the product team to make certain compliance with product documentation in accordance with regulatory requirements ? Coordinate with Global Submissions Manager to ensure timely and accurate submissions to Regulatory Authorities ? Review CMC and bio equivalents data to ensure compliance for assigned generic products ? Liaise with Bausch & Lomb country-specific pharmaceutical regulatory affairs personnel for international submissions and registrations ? Manage interactions with other B&L functions (e.g., Quality, Compliance) during regulatory agency inspections ? Provide regulatory guidance/input to internal product review boards Technical Competencies ? Knowledge of pharmaceutical generic industry regulatory compliance ? Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical Generic products ? Knowledge of clinical development, including responsibilities for successful adherence to development milestones, marketing authorization, meeting facilitation, labeling negotiations, regulatory responses ? Understands regulatory issues related to product patent protection and exclusivity ? Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product regulatory activities for Generic 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 751350 when responding to this ad.
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