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

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.