Senior Associate - United States Regulatory Professional (Obesity and Related Conditions)

Location: United States — Remote

Annual salary: USD 83,974.90–113,613.10

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

• Coordinate and execute U.S. regulatory submissions in compliance with hirify.global standards and FDA requirements.
• Drive submission readiness by coordinating cross-functional inputs, tracking timelines, and verifying complete and accurate deliverables.
• Maintain regulatory records, product regulatory histories, submission content, and agency communications.
• Support U.S. labeling activities and review promotional and non-promotional materials.
• Coordinate and quality-check briefing documents and materials for regulatory agency meetings.
• Support FDA interactions and responses to health authority questions while communicating regulatory updates and risks to stakeholders.

Requirements

• Must be based in the United States.
• Master’s degree in biology, life science, health science, or regulatory science with a biology curriculum; or an equivalent combination of science education and directly related experience.
• Preferred experience in a regulated industry such as biotechnology, pharmaceuticals, medical devices, clinical research, or healthcare.
• Strong written and oral communication, organizational skills, attention to detail, and document-quality focus.
• Ability to manage multiple activities, timelines, and stakeholders, and to identify, communicate, and escalate risks.
• Experience with document management and archiving in a regulated setting is preferred.

Nice to have

• Experience supporting programs in obesity, diabetes, or related metabolic diseases through scientific or clinical work.

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.
• Discretionary annual bonus program and stock-based long-term incentives.
• Award-winning time-off plans and career development opportunities.

Hiring process

• Applications are accepted until a sufficient number of candidates are received or a candidate is selected.
• Sponsorship for this role is not guaranteed.