Regulatory Affairs Manager (Obesity and Related Conditions)

Location: Washington, D.C., United States

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines across oncology, inflammation, general medicine, rare disease, and obesity-related conditions.

What you will do

• Execute U.S. regulatory strategy and deliverables for assigned obesity and related-conditions programs.
• Plan and manage clinical trial and marketing application submissions in alignment with global filing plans and U.S. requirements.
• Provide guidance for regulatory documents, meetings, labeling development, and labeling negotiations.
• Obtain and maintain clinical trial authorizations and marketing approvals, including responses to agency questions.
• Monitor U.S. legislation, regulatory guidance, precedent, and competitor labeling to assess potential impact.
• Partner with global and cross-functional teams, support Health Authority interactions, and proactively manage regulatory risks and compliance obligations.

Requirements

• Doctorate degree, or a master's degree with 2 years of regulatory affairs experience.
• A bachelor's degree with 4 years, an associate's degree with 8 years, or a high school diploma/GED with 10 years of regulatory affairs experience.
• Experience with regulatory submissions and interactions with the FDA.
• Working knowledge of U.S. legislation and regulations for medicinal products and the U.S. registration pathway.
• Experience supporting regulatory strategy, labeling, risk assessment, and cross-functional collaboration.
• Scientific understanding of obesity and metabolic disease, including relevant biological pathways and clinical endpoints.

Nice to have

• Experience in obesity, metabolic disorders, endocrinology, or related therapeutic areas.
• Experience with expedited programs, orphan considerations, pediatric plans, or compassionate use pathways.
• Experience participating in a Labeling Working Group or similar cross-functional regulatory group.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and flexible work models where applicable.