Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes 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, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Senior Manager, Regulatory Affairs centrally located in Boca Raton, FL!
The Senior 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 a liaison with regulatory agencies and affiliates, as well as providing 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.
ESSENTIALS OF THE JOB:
Education Requirements:
Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Master’s degree preferred.
Experience Requirements:
A minimum of ten years of pharmaceutical regulatory experience including at a management level in Regulatory Affairs with an emphasis on Biologics and BLA submission experience.
In addition to competitive compensation, we offer a comprehensive benefits package including:
401K plan with employer match and immediate vesting
Medical, Vision, Life and Dental Insurance
Pet Insurance
Company paid STD and LTD
Company Paid Holidays
3 Weeks Paid Time Off (within the first year)
Tuition Assistance (after the first year)
Easily accessible to Tri-Rail
Free shuttle to the Boca Tri-Rail station
Just awarded 2023 Best Places to Work!
ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.
ADMA Biologics is an Equal Opportunity Employer.
Clear All
0 Top Regulatory Affairs Executive jobs found in West Palm Beach, FL area