Nancy La Rocco Email & Phone Number

River Forest, Illinois

1. Primarily responsible for developing, processing and tracking all regulatory materials for new and existing protocols. Follows Good Clinical Practice (GCP) guidelines within the Federal, State and Institutional regulations and laws. Contributes to positive outcomes and meets the cultural expectations of the organization by exhibiting professional.

Kenosha, WI

1. Prepare clinical study start-up documents per the Sponsor/CRO request2. Prepare and submit reports to the IRB (status reports, change request reports, protocol deviations)3. Communicating with Sponsor/CRO regarding the status and completion of required clinical start-updocuments and any critical regulatory issues.4. Maintaining and reviewing of study.

Lake Forest, Illinois

1. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval2. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports)3. Review/approval of engineering study protocols/reports and validation.

Waukesha, )

Work with a team of Regulatory Affairs professionals to ensure completion of Product Controllership and UDI deliverables in the area of product remediation and new product development. 1. Create Registration program records for US registered products in the IRIS database2. Create US country records for each registration program in IRIS3. Complete UDI.

LAKE Forest, IL

Global Regulatory Affairs Department- Support global device registration tracking project including researching, organizing, collating.- Entering international registration data as well as device definition criteria. - Efficiently data mine database applications such as SAP, Enovia, and RegiSTAR. - Support ordering Certificates of Free Sale, legalizing.

675 Field Drive, Lake Forest, IL

1. Facilitate the execution of Confidential Disclosure Agreements and Clinical Research Areements for all clinical studies and maintains the Master department files.2. Responsible for entering requests for budgetary approval and tracking Agreements in eContract3. Tracking status of PO and ACR payments for department and /in CTMS 4. Manage ACR payments in.

Abbott Park, IL

• Evaluation of regulatory submission or approval data submitted worldwide; resolve deficiencies through research or communication with the appropriate affiliate
• Create submissions or update approvals in the registration data base (TRACTS)
• Monitor and evaluate data in data base, identify issues and determine resolution
• Responsible for accurate recognition and categorization of Regulatory submissions and regulatory documentation as well as comprehensive entry of all materials into the registration tracking database and related.
• Also have mastered a thorough understanding of the EU Regulatory (Centralized Procedure and Mutual Recognition Procedure, Decentralized Procedure) and EU National Clinical Trials Application submission structure and.

• Provided direct support to Associate Directors and External Research Grants Department.
• Reviewed new Investigator Initiated proposals, budgets and drug calculations
• Trained and collaborated with Research Scientific Managers to ensure protocol submissions are complete
• Reviewed study milestone reports, abstracts and manuscripts to determine study relevance and necessity of payment
• Lead contact in establishing requirements for rebuild of Siebel tracking database
• Prepared documents and meeting minutes for External Research Grants Committee meetings

• Provided strategic planning in collaboration with Project Managers to initiate study start-up
• Managed metric tracking of regulatory documents for multi-site trials
• Participation on SOP Development Team relative to regulatory requirements, including staff training
• Management of secured Master Files
• Conducted quality control reviews on master files prior to data locks
• Regulatory expert used to review protocol, all regulatory documents displayed at Investigator meetings