Specialist, Regulatory Affairs

Kaléo(4 years ago)

HybridFull TimeMedior$72,000 - $88,000Regulatory Affairs

About this role

The Regulatory Affairs Specialist at Kaléo plays a key role in ensuring compliance and facilitating regulatory approvals for pharmaceutical and medical device products. The position involves cross-functional collaboration, regulatory strategy development, and managing documentation to support product development and post-market activities.

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Required Skills

Regulatory Affairs
eCTD
Regulatory Documentation
Medical Devices
Pharmaceutical Compliance
Regulatory Strategy
Labeling
Inspection Readiness
FDA
Regulatory Submissions

Qualifications

Bachelor’s Degree in a scientific discipline

About Kaléo

kaleo.com

Kaléo is a commercial-stage biopharmaceutical company that develops patient‑centric therapeutics and drug‑delivery devices to empower patients and families to live fuller, bolder lives. It focuses on emergency care and other high‑impact therapies, and is known for device‑based products such as the Auvi‑Q epinephrine auto‑injector and naloxone rescue therapies. Kaléo combines clinical development, engineering, manufacturing and commercial capabilities to bring innovative solutions to market and partner across the healthcare ecosystem. Its mission, “Solutions for Life,” emphasizes meaningful, practical innovations that improve outcomes and daily living for patients.

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