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An established industry player is seeking a dynamic Executive Director to lead their Regulatory Affairs department. This pivotal role involves overseeing global regulatory strategies, ensuring compliance with industry standards, and managing the regulatory submissions process. The ideal candidate will possess strong leadership skills and a deep understanding of regulatory requirements, particularly in the pharmaceutical sector. This innovative firm values collaboration and proactive engagement with key stakeholders, including regulatory bodies. If you are passionate about driving strategic initiatives and making a significant impact in drug development, this opportunity is perfect for you.
Our premier client is currently seeking an Executive Director / Vice President, Head of Regulatory Affairs. Reporting to the Chief Medical Officer, this position will be responsible for overseeing the global strategy development and execution of the regulatory affairs objectives. They will be a key member of the project leadership teams and will help to inform the design and execution of clinical trials, as well as manage all regulatory submissions for the company. This individual will direct and coordinate activities in regulatory and work with the executive team in formulating strategy, enhancing performance, and administering relevant policies around this critical functional area.
The new hire will provide strategic leadership and key insights that will allow the organization to operate collaboratively and proactively, interacting closely with internal peers and externally with FDA, EMA, and other key stakeholders.
This position has the responsibility for tracking trends and requirements in the global market and the impact that the changes will have on the company’s portfolio. They will also be responsible for analyzing and evaluating the company’s regulatory procedures to ensure the attainment of financial and strategic goals. This includes ensuring that all corporate regulatory goals are clearly defined, met, and are in compliance with all current industry standards globally.
The new hire must be adept at formulating and driving strategy, and also be tactically oriented, preparing and writing submissions and playing a hands-on role in regulatory submissions. Furthermore, this individual will have demonstrated an ability to partner effectively with multiple functions, including Clinical, Research, Development, Medical Affairs and Quality. At a personal level, the company is seeking a highly motivated individual who thrives on being challenged and working in highly collaborative environments to contribute to their cutting-edge science.
Strong interpersonal skills are necessary, as this individual will serve as a voice for the company internally as a trusted member of the team. A proven ability to communicate with other members of the executive management team, Board members, external thought leaders, and research and development staff in a fast-paced environment is crucial. Furthermore, the capacity for strategic thinking is highly important. In short, outstanding leadership and management skills with rigorous scientific intellect and standards and understanding of the business aspects of drug development are required. Finally, an ability to think and manage strategically, with an attention to detail is needed, as is a high energy level, focus, and a passion and sense of urgency for developing significant new medicines for devastating diseases.
Pay Range: $248,000 — $372,000 per year