Director, US Regulatory Affairs - Switch

Site Name: USA - New Jersey - Warren Posted Date: Apr 1 2022 This position serves as a regulatory leader within the Switch Team. As a trusted advisor to cross-functional partners, this individual will lead team to deliver well-constructed and considered regulatory strategies that meet regulatory requirements, business objectives and consumer needs. This is a strategic role with considerable responsibility. The individual must build strong relationships with all stakeholders, internal and external, to guide organizational decision-making and influence positive outcomes. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Growth: Advise the business on the regulatory aspects of Switch. Must be abreast of healthcare trends and how they may impact the regulatory environment and our business. Lead Regulatory assessments of new opportunities, assessing feasibility based on a comprehensive evaluation of the science and the issues likely to be raised by the Switch. Create regulatory strategies that guide the best delivery of Switch innovation. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the evolving regulatory environment. Guide the development and testing of product labeling to achieve regulatory approval and support commercial success. Partner with cross-functional team members to develop competitive advertising and promotion, ensuring risks are appropriately addressed and communicated. Advise on the design of investigational research (labeling, CMC, Clinical) to efficiently and effectively progress development programs at pace. Proactively identify potential regulatory risks and mitigation strategies to enable program acceleration and smart risk-taking. Direct the strategy and execution of INDs and NDAs to achieve on-time submission and first cycle approval. Deliver clear, compelling, and well-constructed regulatory communications for internal and external audiences Lead interactions (meetings, teleconferences) with regulatory authorities to seek guidance, resolve issues and expedite approval of pending applications. Lead and develop regulatory team members to have strong regulatory capabilities and become future leaders. External Engagement: Cultivate external network of key advisors to rapidly leverage expertise when needed. Build strong relationships with the healthcare community, regulators, trade associations and others who are influential in the Self Care/Switch arena to identify regulatory threats and opportunities. Engage in appropriate activities to help shape policy and the regulatory environment. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Life science/Pharmaceutically-related science 10-12 years Regulatory Affairs experience Minimum of 5 years' experience in Consumer Healthcare/OTCs Direct knowledge and practical experience with Rx to OTC switch, INDs and NDAs Preferred Qualifications: If you have the following characteristics, it would be a plus: RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP Ability to understand the business impact of regulatory decisions Strong verbal and written skills Highly skilled in scientific interpretation/evaluation/communication of technical information Ability to influence others and effectively interface with internal and external stakeholders at varying levels of seniority Experience working in cross-functional teams and across a matrixed environment Adept at creative problem-solving Demonstrates mental agility to flex between high level strategy and detailed execution Experience with Medical Devices and/or SaMD Why Consumer Healthcare? Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We're doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year - over a billion and a half of them - and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special. 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