Head of US Regulatory Affairs
About the Company
Respected biopharmaceutical company developing innovative treatments for cancer
Industry
Biotechnology
Type
Public Company
About the Role
The Company is in search of a Head of US Regulatory Affairs to lead and implement strategic and operational regulatory activities for its portfolio, which includes a range of assets from pre-clinical to clinical stages. The successful candidate will be responsible for formulating and overseeing the regulatory strategy for the development of all compounds, maintaining effective communication with regulatory authorities, and leading the US Regulatory Affairs department. This key role requires a professional with a strong work ethic, an entrepreneurial spirit, and a proven track record in regulatory affairs within the life sciences industry, particularly in the field of Hemato-oncology/Oncology with a focus on FDA-related requirements. The Head of US Regulatory Affairs will be expected to have a postgraduate qualification in a relevant field, with a preference for a PhD, research-based MSc, PharmD, or MD, and at least 10 years of experience in the industry. The role involves a wide range of responsibilities, including overseeing all regulatory submissions, preparing for and participating in meetings with US regulators, and providing executive leadership in the development and execution of proactive regulatory strategies. The ideal candidate will have extensive hands-on experience with the FDA, particularly with CBER and OTAT, and a deep understanding of the regulatory landscape for cell and gene medicinal products. They should be a strategic, dynamic, and collaborative leader with exceptional communication, negotiation, and problem-solving skills. The Head of US Regulatory Affairs will also be involved in shaping the company's vision, supporting business development efforts, and ensuring that the department meets corporate goals and remains in compliance with relevant policies and regulations.
Hiring Manager Title
Chief Regulatory Officer
Travel Percent
Less than 10%
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