Feb 11, 2019
As Global Head of Regulatory Affairs you are overall responsible for Product Stewardship and Regulatory Affairs in DuPont Nutrition & Health. You will report to the VP of Technology and Innovation in DuPont Nutrition & Health. You will provide regulatory guidance and strategic direction to senior leadership team and work closely with Technology, Business, Sales, Legal, Quality and Government Affairs to deliver business results. This role is strategically important to the long-term growth plans of the business. DuPont Nutrition and Health is a vibrant business providing healthy, sustainable solutions to the food, dietary supplement and pharmaceutical industries. The strong safety and ethics values of our parent companies (Dow and DuPont) continue to guide us, while we embrace an entrepreneurial culture to drive our future success. If you are looking for an opportunity to shape the future of a business poised for growth, consider joining our team. You will be responsible for leading a team of 50 regulatory professionals located in 20 countries. The team is responsible for the regulatory approval of food, dietary supplement and pharmaceutical excipient products as well as influencing regulations, legislation and industry protocols to the benefit of company interests. Key responsibilities: Provide strategic regulatory direction on the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management. Drive regulatory leadership to support product development and ensure successful implementation and execution of regulatory plans to support product approval and commercialization. Provide regulatory due diligence assessments of new business opportunities as required Understand and interpret regional laws, regulations, guidance, and global regulatory and political developments while ensuring that elements, quality, accuracy and format of regulatory submissions comply with applicable laws and regulatory standards, Build partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and ensuring appropriate resources are allocated Liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to product development including resolution of key regulatory issues and to expedite approvals of products. Guide, coach and manage a team of regulatory professionals to ensure their professional development and advancement Job Qualifications The successful candidate has at least 10 years of experience in Regulatory Affairs in biotechnology, pharmaceutical, medical, dietary supplement or related industries, including an in-depth knowledge and understanding of the Regulatory environment. International experience is a plus. You hold minimum 5 years of experience managing a team of regulatory professionals and you have demonstrated good leadership skills in defining novel approaches to product approvals, regulatory issues and navigating health authority requests. A thorough understanding of relevant regulations and guidelines is a requirement. You thrive in an international environment driven by values and a strong company culture. You are motivated by contributing to an innovation-driven business with focus on growth and sustainability where strong strategic skills and business acumen are essentials. You enjoy motivating people and take pride in the development and success of your team. You have strong interpersonal skills, and is experienced navigating in a complex matrix organization. Excellent verbal and written skills are key; combined with the ability to analyze and effectively convey difficult and complex issues to internal and external stakeholders, including Senior Management. Flexibility and sensitivity to work with many cultures and across time zones is crucial to be successful in this position What we offer: DuPont Nutrition & Health is a USD 4.7 billion global business and one of the world’s largest producers of specialty food ingredients, developing and manufacturing solutions for the global food & beverage, nutrition and pharma market. With more than 8,500 employees, 50+ manufacturing sites and 20+ R&D centres across the world, N&H is on a mission to make food safer, more sustainable, better tasting and more nutritious. N&H is part of DowDuPont, a globally listed company, which came to life following the merger of Dow Chemical and DuPont in 2017. DowDuPont has a turnover of approximately $62 billion, employs around 98,000 FTEs and is headquartered in Wilmington, USA. At DuPont, we are dedicated to maximizing our most valuable asset—our people. We do so by embracing diversity and offering opportunities for continuous development, whilst maintaining a good work/life balance. Our compensation package includes a competitive base salary, variable performance pay and a comprehensive benefits offering. A career at DuPont offers you an opportunity to become the catalyst for change, personally and professionally. This, together with a respectful workplace that rewards achievement, makes DuPont one of the best career choices today.
DuPont Nutrition & Health Copenhagen, Denmark Full time