Head of Regulatory Affairs

Head Regulatory AffairsLocation: RemoteStep into a pivotal leadership role (VP Level) where your expertise in regulatory affairs will shape the future of a transformative biopharma company. My client is on a mission to empower patients battling rare and serious liver diseases. Lead the charge in regulatory strategy for the approval of cutting-edge treatments, an FDA Fast Track and orphan drug designated therapy. This role offers the unique opportunity to drive commercial success while improving lives on a global scale.Why You Should ApplyDirect the regulatory pathway for life-saving treatments.Collaborate with top-tier global regulatory experts.Build and lead your own US Regulatory Affairs team.Hybrid work environment for work-life balance.Amazing Compensation packageAbility to work in a stable organization with revenue stream What You’ll Be DoingLeading the development and execution of regulatory strategies for US FDA approvals.Building and mentoring a high-performing US Regulatory Affairs team.Collaborating across functional areas, including Pre-clinical, Medical, and Commercial teams.Managing IND submissions, label development, advisory committee preparations, and more.Guiding global regulatory compliance and promotional review.About YouBachelors degree and ideally a Masters in Regulatory10+ Experience with accelerated approval pathways and rare disease products.Proven success with multiple US FDA product submissions and approvals.Strong leadership skills, capable of building teams and navigating complex regulatory processes.Flexibility and resilience in a fast-growing organization.How To ApplyWe’d love to see your resume, but we don’t need it to have a conversation. Send us an email to ava@scientificsearch.com and tell me why you’re interested. Or, feel free to email your resume. Please include Job #18707. #LI-Remote #LI-AG1Type: Direct HireCategory: Pharmaceutical CompanyDate Posted: 2024-11-18