Senior Director Usra

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Senior Director USRA
Duties: Be the functional regulatory expert to the business on US OTC Drug regulations, providing strategic regulatory direction on new projects/ideas. Set standards and build capabilities for the USRA OTC Drug team. Manage resources to effectively deliver innovation and stewardship of the OTC Drugs US portfolio. Strong business partner to commercial counterparts, use Regulatory insights to guide and shape the portfolio. Use regulatory expertise to shape the strategy and execution of New Drug Applications for the portfolio, guiding teams to identify innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment. Key advisor on US Monograph interpretation for products within portfolio, providing guidance to business and other stakeholders. Build and maintain strong collaborative relationships with Global and US stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS. Manage resources to provide Regulatory support and guidance to ex-US markets for brands where US is the Lead Market (as defined through SRA). Lead interactions (meetings, teleconferences) with US FDA in order to seek guidance, expedite approval of pending applications and to resolve regulatory matters in line with GSKs position. Develop direct reports to have strong regulatory capabilities. Accountable for the ongoing end-to-end regulatory compliance of products in remit. Guide staff in the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated. Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business. Maintain high level of knowledge on the science of products within defined portfolio. Key internal advisor on existing and emerging trends for products/categories in remit. Anticipate threats and opportunities. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action. External regulatory environmental engagement to further the business goals; drive key actions (inc assessment and build on industry and competition trends) and ensure key issues/threats are managed via the regions/markets.

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