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 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 within ADMA. 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, we offer a comprehensive benefits package including:
Fast growing company. Redesigning HR of the future for ADMA. Benefit eligible on day 30. 100% paid dental, eye care, life insurance, STD and LTD. 75% employer paid medical with low premiums. PTO of 12 per year for first two years and then goes up from there, holidays, three floating holidays. 4% match 401k vested from day 1. Pet insurance with very low premium.
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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.
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