Sr. Regulatory Affairs Associate
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 Regulatory Affairs Sr. Associate!
The Regulatory Affairs Sr. Associate, will manage and participates in the planning, organizing and interpreting of regulatory documents for submission to governmental regulatory agencies.
- Maintain IND's and BLA's for various products; prepare and submit annual reports and final clinical reports to appropriate agencies.
- Manage the preparation and submission of IND's, BLA's, CTD's, NDA's and OD's to regulatory agencies, etc.
- Manage the lifecycle of BLA and IND sections.
- Serve in advisory role to project teams regarding regulatory requirements and strategy development; keep management and team members abreast of project status and adherence to project deadlines.
- Review and interpret industry-related regulations and guidance's (both US and foreign) to serve as informational resource where needed.
- Ensure corporate policies and procedures are in full compliance with regulatory requirements and are being followed.
- Serve as liaison with other company personnel, corporate partners and regulatory agencies to assist the project in staying on track and moving forward.
- Asses and approve internal quality systems to ensure compliance with applicable applications and FDA regulations.
Education Requirements: Bachelor's Degree in health or science-related field.
Experience Requirements: At least five years of practical science or regulatory 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 and Personal Days
- 3 Weeks' Paid Time Off (within the first year)
- Tuition Assistance (after the first year)
- Easily accessible to Tri-Rail
- Company paid shuttle to the Boca Tri-Rail station
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.