Dir US Regulatory Affairs Liaison
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About The Position
At Bayer, we are visionaries driven to solve the world's toughest challenges, striving for a world where 'Health for all, Hunger for none' is not just a dream but a real possibility. We approach our work with energy, curiosity, and sheer dedication, always learning from the unique perspectives of those around us. As the Director of US Regulatory Affairs Liaison, you will develop US regulatory strategies for key projects, ensuring fast and resource-efficient submissions of high-quality dossiers. You will drive communications and negotiations with the Food and Drug Administration (FDA) to achieve timely product approvals with optimized labeling. This role requires a deep understanding of both the business objectives and priorities of the Country Divisional Heads and the Global Regulatory Head, as well as the Research and Development (R&D) organization. In this position, you will inspire and train US regulatory staff through the principles of visionary leadership, acting as an architect, catalyst, and coach. You will develop functional capabilities, create an inclusive and diverse environment, build a talent bench, and drive a transparent and vibrant learning culture based on company values. As a Regulatory Expert, you will lead complex projects for high-priority programs to achieve US registrations. Your responsibilities will include defining regulatory strategies, collaborating with cross-functional teams, and ensuring compliance with all regulatory and legal obligations. You will also oversee the development of submission materials, guide the review process, and ensure the quality and scientific consistency of submission documents. Your role will involve proactively identifying regulatory risks and developing mitigation plans, as well as leading negotiations with the FDA to ensure timely approvals. You will work closely with Market Access, Medical Affairs, and Commercial teams to align regulatory outcomes with key market strategies. Additionally, you will play a leadership role in special projects aimed at continuously improving Regulatory Affairs activities, ensuring that key pipeline products comply with FDA regulations and Bayer's internal processes.
