Global Head, Regulatory Affairs - Denmark
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- Our company is now searching for a Global Head, Regulatory Affairs, at our headquarters.
- The Global Head, Regulatory Affairs, will be responsible for setting the regulatory strategy and building a department ready and fit to support the company in future challenges.
- We are looking for a strong leader, who can build, organize and lead regulatory activities and a regulatory team on a worldwide basis.
- The main focus of the role will be to provide strategic input for all regulatory activities, such as filings as well as preparing and overseeing regulatory submissions to any international health authority – including management and oversight of timely delivery of documentation for research, nonclinical and clinical development.
- You are an experienced Regulatory Affairs executive with 10 – 15 years of experience that will have included a substantial period in an international leadership role in the pharmaceutical industry, ideally in the therapeutic area of oncology or hematology and/or orphan drugs.
- Previous experience in the development and registration of biologics would be a plus.
- You are a strategist and at the same time also a hands-on expert.
- A progressive and proven record of leadership and managing regulatory organisations with global responsibilities must be demonstrated.
- Critical thinking, strong planning and project management will be a given, as is the ability to prioritize and analyse data.
- Also strong personal ethics and values are important.
- We are looking for a team player and strong communicator with excellent social skills and with an open mind, as teamwork, knowledge sharing and innovation are the keys to our success.
- You hold a relevant university Master degree and ideally a post-graduated qualification.
- Our company is a small biotech company with a short chain of command.
- You will have opportunity to influence your own work as well as your personal and professional development.
- You will also have flexible working hours and conditions.
- With a solid financial basis due to our partnerships with large international companies combined with our own pipeline of potential products, we have a promising future.
- Our commitment to bringing new medicines to the market to improve patients’ lives is a strong motivation for employees at our company.
- Our aim is to foster a culture of excellence and innovation where employees are focused on clear priorities and are passionate about innovation.
- We work cross-functionally and internationally as one team to gain the most from all competencies.
- Our employees work with determination and with respect for each other to achieve our tasks and common goals.
- We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company.