Position Summary

Responsible for the regulatory compliance of the Plasma Services Organization. Acts as the designated company authorized official for all communications with regulatory agencies regarding Plasma related issues. Supervises and participates in planning, preparing and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA). This position provides advice and direction regarding regulatory requirements.

Essential Functions (ES) and Responsibilities

Provides leadership and support to Plasma Operations, Center Management, and Plasma Corporate staff to ensure regulatory compliance by Center facilities and Plasma organization.

Reviews and interprets all applicable regulations governing Plasma processes and procedures to ensure full compliance.

Ensures Plasma Centers are in compliance with all governing agencies through inspections, reporting and follow up of issues; recommend corrective and preventive actions as necessary.

Is available to regulatory authorities during inspections to ensure appropriate information is supplied as requested. Accompany FDA inspectors for pre-scheduled new center audits.

Prepares submission of Biologics License Applications (BLA's) associated to center establishments and plasma products and CLIA/COLA licensing as related to Plasma Center operations.

Prepares FDA Annual Report as it relates to the Plasma organization.

Assists Plasma QA and Operations in the crafting audit and inspection responses.

Provides consultation regarding Lookback, Post-Donation and Error/Accident, and BPDR situations as requested.

Initiates Recalls and follows up with the FDA, other applicable regulatory agencies and customers as required.

Responsible for review and approval of new and revised Plasma Center Standard Operating Procedures (SOP's), and review of related training materials regarding applicable regulations to ensure compliance.

Interfaces with Plasma Operations Management, Plasma QA, Medical Director, and other departments, making regulatory decisions and recommendations as applicable and required.

Serves as representative and advisor to Plasma management concerning regulatory requirements and their impact on processes and procedures.

Responsible for the preparation, review, presentation, and publishing of FDA submissions to assure accuracy and completeness of submission documents, which includes but is not limited to meeting requests/briefing packages and presentations to the FDA (e.g., preIND/pre-BLA, end-of-phase II, Type A,B or C, and advisory committee meetings), Investigational New Drug Applications (INDs), Biologic

License Applications (BLAs), Marketing and Promotional Materials, Product Listing and Establishment License Applications, and other related documents or CMC supplement submissions.

Develops regulatory strategies, determines submission requirements and requests necessary data, information, and documentation from pertinent departments and Subject Matter Experts (SMEs), as needed.

Assures supplements and amendments to INDs/BLAs are completed within specified regulatory timeframes. Reviews and approves all materials to be included in submissions for accuracy and completeness, which include stability, validation and investigation reports, product testing data and information packages prepared by SMEs.

Participates and provides regulatory support during audits and FDA inspections as necessary.

Oversees regulatory operations by tracking submissions and Post Marketing Requirements/Commitments. Maintains investigational and marketing applications and SOPs. Appropriate knowledge of eCTD format and submission software systems.

Reviews and evaluates change controls and deviations to determine regulatory impact and reporting requirements. Evaluates, prepares and submits Biological Product Deviation Reports as necessary.

Advises Project Teams regarding regulatory requirements; serves as Project Team member to ensure primary and alternate strategies are appropriately explored.

Serves in advisory roles to project teams regarding regulatory requirements and strategy development; keeps management and team members abreast of project status and adherence to project deadlines.