Associate, Regulatory Affairs

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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 an

Job Title: Associate, Regulatory Affairs

Job Description:

Position Summary

The Associate, Regulatory Affairs, is 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). Ensure corporate policies and procedures comply with regulatory requirements.

Essential Functions (ES) and Responsibilities

• Analyzes current FDA Guidance and determines regulatory strategy prior to performing assigned tasks.
• Provides support to the ADMA team related to FDA regulations/guidance 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 guidance 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.

Job Responsibilities or Job Requirements

Competencies

Ability to follow the cGMP's and procedures with great attention to detail

Ability to understand and interpret government regulations and customer specifications

Able to evaluate and interpret regulations and recognize the need for appropriate changes relative to procedures

Able to work in high-pressure, deadline-driven environment

Experience Requirements

• Understands, follows, and revises SOPs and complies with GMPs as required by the FDA.
• Trends data in preparation for Annual Product Quality Reports (APQR).
• Participate 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 the pharmaceutical industry or other FDA regulated industry with some laboratory and cGMP knowledge. Biologics experience preferred.

Preferred Experience

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

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In addition to competitive compensation, we offer a comprehensive benefits package including:401K plan with employer match and immediate vestingMedical, Vision, Life and Dental InsurancePet InsuranceCompany paid STD and LTDCompany Paid Holidays3 Weeks' Paid Time Off (within the first year)Tuition Assistance (after the first year)Easily accessible to Tri-RailFree shuttle to the Boca Tri-Rail stationADMA 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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