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DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health Serviced and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002February 16, 2017 Advanced
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What is senior regulatory affairs program?
Senior regulatory affairs program is a comprehensive plan developed by a company to ensure compliance with regulatory requirements in the industry.
Who is required to file senior regulatory affairs program?
Typically, companies in highly regulated industries such as pharmaceuticals, medical devices, and biotechnology are required to file senior regulatory affairs programs.
How to fill out senior regulatory affairs program?
Senior regulatory affairs programs are typically filled out by regulatory affairs professionals within a company who are responsible for ensuring compliance with regulations.
What is the purpose of senior regulatory affairs program?
The purpose of senior regulatory affairs program is to establish processes and procedures within a company to comply with regulations and maintain market authorization for products.
What information must be reported on senior regulatory affairs program?
Information that must be reported on senior regulatory affairs program includes regulatory requirements, compliance activities, risk assessments, and corrective actions.
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