Director Global Regulatory Affairs

As a Global Strategy Leader for a pharmaceutical portfolio, you will play a crucial role in leading the strategic direction and execution of regulatory strategies. Your responsibilities will include: - Developing global regulatory strategies for the company's pharmaceutical portfolio, such as IND/CTAs, NDAs, NDSs, MAAs, and other key regulatory submissions. - Collaborating with senior leadership in various functional areas to align regulatory strategy with overall product development and business objectives. - Providing expert guidance on regulatory requirements, market access strategies, and potential risks to inform decision-making across the organization. - Overseeing the planning, preparation, and execution of global regulatory submissions to ensure timely approval and market access across key regions (e.g., FDA, EMA, Health Canada, etc.). - Serving as a regulatory contact for cross-functional teams to ensure alignment on regulatory strategy and execution across global markets. - Identifying and managing regulatory risks associated with the global development and commercialization of pharmaceutical products. - Leading, mentoring, and developing a high-performing team of regulatory professionals. - Assessing and anticipating the competitive landscape and market trends to inform regulatory strategy and market access plans. Qualifications and Required Skills: - Education: Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field (Advanced degree preferred). Regulatory Affairs Certification (e.g., RAC) is a plus. - Experience: 12+ years of regulatory affairs experience in the pharmaceutical industry, with expertise in regulatory strategy, submissions, and global market access. - Skills & Competencies: Strategic thinker with deep understanding of global regulatory environment, exceptional leadership and team-building skills, strong project management abilities, excellent communication and negotiation skills, analytical mindset, and proven ability to navigate complex regulatory landscapes. The job requires 10-15% domestic and international travel. The position also offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave, and potential for performance-based bonuses. Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.,