Associate Regulatory Affairs

3 weeks ago

Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time
Job Details

Job Location
ADMA Biologics FL - Boca Raton, FL

Travel Percentage
None

Job Shift
Day

Description

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 Associate, in Boca Raton, FL

The Regulatory Affairs Associate Responsible for participating in the planning, preparing, and evaluating of regulatory documents for submission to governmental regulatory agencies including the U.S. Food and Drug Administration (FDA). Ensures corporate policies and procedures comply with regulatory requirements.

Qualifications

Essentials of the Job:
  • Analyzes current FDA Guidances and determines regulatory strategy prior to performing assigned tasks.
  • Provides support to the ADMA team related to FDA regulations/guidances and applicable International requirements.
  • Participates in cross-functional investigations, assesses the need for Biological Product Deviation Reports (BPDRs) and when applicable submits these to the FDA.
  • Responsible for accurate and timely processing of regulatory submissions, and the preparation/publication of electronic Common Technical Documents (eCTDs).
  • Updates departmental Standard Operating Procedures (SOPs) as required.
  • Interprets regulatory guidances or guidance changes and ensures that they are communicated appropriately to the ADMA team and included as necessary in corporate policies and procedures.
  • Prepares BLA Annual Reports for products manufactured by the company in which impacted change controls are reported.
  • Prepares or directs the preparation of additional information or responses as requested by regulatory agencies by collaborating with SMEs from multiple departments.
  • Tracks regulatory activities using systems like SmartSheet and SharePoint.
  • Evaluates and writes assessments related to Quality Systems (Change Controls, CAPAs and Deviations as applicable).
  • Prepares and submits technical files such as Lot Distribution Data (LDD) reports to the FDA for all manufactured products.
  • Understands, follows, and revises SOPs and complies with GMPs as required by the FDA.
  • Trends data in preparation for Annual Product Quality Reports (APQR).
  • Participates in ongoing training and compliance activities.
  • Balances competing priorities through deliberate project and time management practices.
Represents regulatory department at cross-functional meetings such as Change Review Board, Quality Review Board, Supplier Quality Assessment (CRB, QRB, SQA).

Education Requirements : Bachelor's Degree required.

Experience Requirements: A minimum of 1 year experience in Plasma or related field or FDA regulated industry with some laboratory and cGMP experience. Some general office experience helpful, typing and customer service; experience in plasma center operations preferred.

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
  • Free 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.

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