Director of Regulatory -Drug/Device Submissions-
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.
Our Director of Regulatory is responsible for coordinating and meeting all regulatory requirements of the SmartPractice business worldwide.
- 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
- 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.