Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Our client is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. . If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider to apply to this position We currently have an exciting opportunity available for a Manager, Regulatory Affairs in Boca Raton, FL!
The Manager, Regulatory Affairs supervises and participates in planning, preparing and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA). Serves as an informative regulatory resource for cross-functional teams. Provides regulatory guidance to address FDA questions for both investigational and market product applications. Ensures corporate policies, procedures and manufacturing/testing activities comply with regulatory requirements and approved INDs/BLAs.
Education Requirements:
Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Master’s degree preferred.
Experience Requirements:
7-10 years' experience in Biologic Regulatory Affairs function with FDA, cGMP and cGCP experience. Experience with both personnel and project management. CBER and BLA experience is essential.
Effective written and verbal communication skills
In addition to competitive compensation, they offer a comprehensive benefits package including:
Easily accessible to Tri-Rail Free shuttle to the Boca Tri-Rail station