Specialist, Regulatory Affairs
Kaléo
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.
Skills
Qualifications
About Kaléo
kaleo.comKaléo 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.
Recent company news
GlobeNewswireKaléo Strengthens Leadership Team to Advance Drug Delivery and Autoinjector Innovation
1 month ago
Fierce PharmaKaléo unveils 58 layoffs days after pledging to double in-office commercial team for EpiPen rival Auvi-Q
Oct 7, 2024
Pharmaceutical TechnologyMarathon Asset Management to acquire pharmaceutical firm Kaléo for $310m
Nov 30, 2021
Medical Marketing and MediaFDA slaps Kaléo for ‘misleading’ Brittany Mahomes Instagram post
Jul 30, 2024
The New York TimesExpress Scripts Sues Maker of Overdose Drug, Intensifying Feud (Published 2017)
May 31, 2017
About Kaléo
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
Unlock Company Insights
View leadership team, funding history,
and employee contacts for Kaléo.
Salary
$72k – $88k
per year