Vice President Regulatory Affairs About the Company Pioneering biopharma company
Industry
Pharmaceuticals
Type
Privately Held
About the Role The Company is seeking a VP 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 for cutting-edge treatments, including those with Fast Track and orphan drug designations.
This role involves directing the regulatory pathway for life-saving therapies, managing IND submissions, label development, and advisory committee preparations, as well as guiding global regulatory compliance and promotional review.
The VP will also be tasked with building and mentoring a high-performing US Regulatory Affairs team and collaborating across various functional areas, including pre-clinical, medical, and commercial teams.
Applicants for the VP of Regulatory Affairs position at the company should have a Bachelor's degree, ideally a Master's, in a relevant field, with a minimum of 10 years' experience in regulatory affairs, particularly with accelerated approval pathways and rare disease products.
The role requires a proven track record of success with multiple US FDA product submissions and approvals, strong leadership skills, and the ability to navigate complex regulatory processes.
The ideal candidate will be flexible and resilient, capable of thriving in a fast-growing organization, and will have the opportunity to work in a hybrid environment that promotes work-life balance.
Travel Percent
Less than 10%
Functions Medical Care/Hospital Administration