Job Description

Ready to work for one of the Healthiest Employers in the Valley? 
Because we have won this award for five years running! We are a family-owned company dedicated to helping health care professionals by providing high-quality supplies, services, and patient communications. Our employees are a key part of our success and we actively recruit people who have a drive for excellence, a customer is king philosophy, and an entrepreneurial spirit.

Position Summary
Our Director of Regulatory is responsible for coordinating and meeting all regulatory requirements of the SmartPractice business worldwide.  

Responsibilities
- Complete the BLAs/submissions for new drug and device products to various regulatory agencies worldwide   
- Develop relationships with global regulatory agencies including but not limited to the FDA, PEI, AIFA, Health Canada, EMA, and Japan
- Coordinate with multi-national business locations to ensure regulatory compliance
- Manage eCTD and other global document filings to ensure proper formatting and language is used
- Understand drug and device regulations, updating senior management as necessary for critical changes
- Support regulatory audits both in the U.S. and globally as required

Qualifications 
- Minimum of seven years demonstrated experience in regulatory management required
- Experience with drug/pharmaceutical submissions required
- Experience with the FDA as well as international regulatory agencies required
- Experience with multi-national sites required 
- Word, Excel, and PowerPoint experience required
- Experience with eCTD programs preferred 
- ISO experience a plus
- Ability to travel 15-20%, including internationally 

In support of our mission statement, "Healthier Practices, Healthier Patients", we have adopted a tobacco-free environment and we choose not to hire tobacco and nicotine users including the use of e-cigarettes.
EEO/AA/M/F/Disability/Vet

Application Instructions

Please click on the link below to apply for this position. A new window will open and direct you to apply at our corporate careers page. We look forward to hearing from you!

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