Head Of Regulatory Affairs

Head of Regulatory Affairs About the Company Pioneering biopharma company

Industry
Pharmaceuticals

Type
Privately Held








About the Role The Company is seeking a Head of Regulatory Affairs to take on a pivotal leadership role in shaping the future of the organization. The successful candidate will be responsible for leading the development and execution of regulatory strategies, with a focus on US FDA approvals. This includes managing IND submissions, label development, and advisory committee preparations. The role also involves guiding global regulatory compliance and promotional review, as well as building and mentoring a high-performing US regulatory affairs team. The ideal candidate will have a Bachelor's degree, ideally a Master's in regulatory, and at least 10 years of experience with accelerated approval pathways and rare disease products, with a proven track record of multiple US FDA product submissions and approvals.

Applicants for the Head of Regulatory Affairs position at the company should possess strong leadership skills, be capable of building teams, and have the ability to navigate complex regulatory processes. The role requires a candidate with flexibility and resilience, particularly in a fast-growing organization. The Head of Regulatory Affairs will have the opportunity to collaborate with top-tier global regulatory experts and will be at the forefront of the company's mission to empower patients with rare and serious liver diseases. This is a unique opportunity to drive commercial success while making a significant impact on a global scale.




Travel Percent
Less than 10%

Functions Medical Care/Hospital Administration