Regulatory Affairs, Sr Manager Obesity and Related Conditions (Biotech)

Location: United States; corporate headquarters in Thousand Oaks, California, with Washington, D.C. listed in the posting.

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for patients worldwide.

What you will do

• Develop and execute U.S. regulatory strategies for global programs in obesity and related cardiometabolic conditions.
• Represent the U.S. on global regulatory teams and contribute to development, registration, and lifecycle-management strategies.
• Plan and lead U.S. regulatory submissions, including clinical trial and marketing applications.
• Develop regulatory documents, labels, briefing packages, and submission components.
• Lead FDA and other health authority interactions, coordinate responses to agency questions, and communicate outcomes to senior stakeholders.
• Assess regulatory risks, monitor U.S. regulatory intelligence, and ensure ongoing compliance with product commitments and obligations.

Requirements

• Doctorate degree and 2 years of regulatory experience; or master's degree and 4 years; bachelor's degree and 6 years; associate's degree and 10 years; or high school diploma/GED and 12 years.
• Demonstrated experience with U.S. regulatory submissions and direct FDA interaction.
• Strong knowledge of the U.S. regulatory environment and drug development lifecycle.
• Experience contributing to regulatory strategy, risk assessment, scenario planning, and health authority engagement.
• Experience working with policies, procedures, and SOPs in a regulated environment.
• Ability to collaborate with Clinical, Medical, Safety, Commercial, and global regulatory teams.

Nice to have

• Experience in obesity, metabolic disorders, endocrinology, or related therapeutic areas.
• Scientific literacy in metabolic pathways, weight regulation biology, and relevant clinical endpoints.
• Experience leading U.S. labeling strategy and negotiation.
• Experience with regulatory submissions or health authority interactions outside the U.S.

Culture & Benefits

• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.
• Flexible work models where applicable.