SUMMARY

• Hands - on Project Manager wif over 5 years’ project management experience wif Fortune 500 pharmaceutical companies and an extensive background in regulatory processes including remediation protocols, quality assurance and compliance.
• Strengths include Data Analysis, determining Trends & Systemic issues, Managing Change Controls, Regulatory Compliance, Labeling and Submissions using Quality System TrackWise globally.
• Excellent people communication and presentation skills; reports directly to the President, VP or Director level throughout career.
• Extensive experience in the Pharmaceutical Industry in leadership and hands-on roles in the areas of: CMC data/documents, IND / NDA / ANDA, BLA’s, ICH guidelines (i.e. Medication Delivery Systems Specializing in Oncology, Cardiovascular, Renal, and Hematology Transfusion Therapies etc..) Regulatory submissions models and activities, data and text documents / sections.
• Ensured dat all application are filed in accordance wif predetermined timelines.
• Strong knowledge of FDA and ICH guidelines, (CFR 820 Part 11) and MDR / Medwatch requirements. Also, ensured dat the methodology used and experimentation performed met validation and verification requirements via Quality System TrackWise.
• Coordinated NDA/ANDA/ INDs/ BLAs submission activities of drug products. Assisted in preparation and submission dat met company objectives wifin budget and established timeframes.
• Experience wif compiling ad hoc requests in Excel, approving change controls in SQL for B2One go live roll out on a Global scale.
• Responsible for executing proactive gap assessment remediation activity in accordance wif project milestones of levels 1, 2 and 3 identified gaps.
• Highly motivated and results oriented professional wif exceptional leadership and a solid track record of consistency and exceeding company goals.
• Knowledge of SOP’S, HIPAA, Matrix’s, cGMP, CMC, USP and FDA Guidelines.

TECHNICAL SKILLS

• Excel
• Word wif ISI Writer
• Access
• PowerPoint
• Outlook
• Word Perfect
• Lotus Notes
• Project. eCTD
• TrackWise
• J D Edwards
• SQL
• SAP
• The Registration And Compliance Tracking System (TRACTS)
• Adobe
• GDR
• SharePoint.

PROFESSIONAL EXPERIENCE

Confidential, Lake Forest, IL

Regulatory Affairs Project Manager

Responsibilities:

• Assessed global regulatory risk to currently marketed products and recommends remediation, as necessary, to bring products into compliance globally in a complex environment.
• Manages the preparation and review of registration packages to ensure TEMPeffective data presentation and quality.
• Managed, edit and developed protocols per FDA guideline to meet required specifications.
• Strong knowledge in FDA and ICH guidelines, and ANDA /NDA requirements, ensured dat the methodology used and experimentation performed met validation and verification requirements.
• Lead and trained junior regulatory affairs specialist in identifying gaps.
• Provided support and mentored to junior specialist in the redlining process according to SOPs and Corporate policies.
• Maintained scheduled timeline of gap remediation for final approval
• Responsible for executing gap remediation activity in accordance wif project milestones.
• Identified regulatory activity and interact wif cross functional teams such as QC, Chemistry, Stability and Microbiology.
• Communicated status of remediation and issues on a timely basis wif peers.
• Revised regulatory submission files and other regulatory documents as required.
• Reviewed regulatory application history to facilitate remediation, as needed.
• Responsible for tracking and completion of assigned remediation activities.
• Interfaced wif other cross-functional /departments for TEMPeffective of remediation activities.
• Accountable for TEMPeffective communication of remediation status including issues and modification to action plans.
• Responsible for determining trends and systemic issues and suggests process improvements based on observations per SOPs.

Confidential, Lake Forest, IL

Regulatory Affairs Project Manager

Responsibilities:

Responsible for executing proactive gap assessment remediation activity in accordance wif project milestones.

• Identified regulatory activity and interact wif cross functional teams to execute action such as QC, Chemistry, Stability and Microbiology.
• Communicated status of remediation and issues on a timely basis.
• Revised regulatory submission files and other regulatory documents such as SOPs as required.
• Reviewed regulatory application history to facilitate remediation, as needed.
• Responsible for tracking and completion of assigned remediation activities.
• Accountable for accuracy of work and meeting multiple, simultaneous deadlines.
• Responsible for TEMPeffective cross-functional coordination of remediation activities.
• Accountable for TEMPeffective communication of remediation status including issues and modification to action plans.
• Prepared and issued reports.
• Evaluated regulatory information to accurately and efficiently maintain registrations and make improvements as necessary, wif oversight.
• Analyzed data from various quality inputs.
• Responsible for determining trends and systemic issues.

Confidential, Vernon Hills, IL

Regulatory Affairs/Consultant

Responsibilities:

• Responsible for monitoring the change control process and ensured through to closure for our medication delivery systems ( i.e. oncology, renal, hematology etc).
• Coordinated activities between functional work streams and quality teams such as QC, Chemistry, Micro, and Stability to improve CMC strategies wifin the change control process. .
• Followed up wif change controls and ensure closure satisfying requirements.
• Perform interim and final review and determine acceptability by using acceptance criteria on all change requests.
• Performed final review of test results for completeness and assurance dat change request requirements has met the requirements.
• Maintained files such dat documents are readily available for inspection.
• Accumulated all required documentation for a change request and perform cross checks on requirements.
• Involved wif resolving issues wif Functional /Technical Leads to assure acceptability of change request.
• Responsible for the tracking of change request in SharePoint.
• Assisted and coordinated the change process for B4One (Global ERP).
• Managed change control activities. Updated necessary documentation and confirmed evidence in test management tool.
• Coordinated and lead team meetings via Webex.

Confidential, Lake Forest, IL

Regulatory Project Coordinator

Responsibilities:

• Coordinator for a government regulated (FDA) manufacturing environment.
• Coordinating the deactivation process of grandfatheird NDA and ANDA products for wifdrawal by preparing wifdrawal submissions for management review.
• Prepare Change Request Forms (CR’s) for the deactivation of wifdrawn products 0ct Detail Management, (RDA) Registered Document Analysis, (RPT) Registration Planning and Tracking, (SPT) Submission Planning and Tracking.
• Evaluates overall compliance to Abbott policies, ICH Guidelines, country-specific regulations, and other applicable regulations and standards.
• Responsible for reviewing and entering important information from regulated documents, such as protocols, investigator brochures, clinical study reports, periodic safety update reports (PSURs), and Labeling updates.
• Responsible for reviewing, updating and entering the Notice of Regulatory Approval (NORA), Notice of Regulatory Submission (NORS) and Notice of Regulatory Wifdraw (NORW) into TRACTS System.

Confidential

Supply Chain Specialist

Responsibilities:

• Supported the creation and development of demand forecasts, component order plans, and finished good production schedules. Collaborated wif internal teams and contract manufacturers to execute plans and ensure appropriate inventory levels are achieved.
• Supported management of daily distribution activities to support the Takeda network.
• Worked wif Materials Management, Customer Service, and Third Party Contractors to improve the overall supply chain. Assisted in determining appropriate capacities and resources are available to produce inventories required to support the supply of on-market products.
• Worked wif Third Party Manufacturers (TPMs) and assisted the internal team wif improving TPM performance (cost reduction, cycle times, etc) throughout the product life cycle.
• Supported cross-functional product/project teams.
• Gained international trade exposure wif knowledge of import and export processes and exposure to U.S. Customs and Border Protection, FDA and USDA.
• Served as an ambassador for Takeda in interactions wif outside contractors.
• Received extensive one-on-one mentoring from Inventory Planning Managers, Distribution Managers, and Upper Management.

Confidential, Maple Grove, MN

Post-Market Regulatory Compliance Project Manager

Responsibilities:

• Managed customer complaints to determine which are regulatory reportable and worked as a key contact for activities wif internal, field, and end use customers. Responsible for adherence to, and interpretation and implementation of, Good Manufacturing Practices (GMPs) and proper complaint handling per the Code of Federal Register (CFR) and other governmental regulations. Communicated event investigation results via regulatory reports and written communications, as appropriate.
• Review complaint communications and assess for regulatory compliance, report ability, and potential impact to patient safety and business operations.
• Served as an internal consultant on regulatory issues, field actions, and report decision-making. In addition to writing, reviewing, and auditing departmental Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensured timely transmission to the appropriate regulatory authorities.
• Coordinated, developed and delivered presentations to global regulatory agencies. Topics included regulatory reporting strategies, compliance issues, or new initiatives.
• Complaints filed were regarding cardiovascular, oncology therapy, renal, hematology transfusions etc.

Confidential, Morton Grove, IL

Complaint Manager, Compliance Department, Quality & cGMP

Responsibilities:

• Managed the information content of customer communications (e.g., calls, emails, written correspondence) dat allege deficiencies related to the quality, durability, reliability, safety, TEMPeffectiveness, or performance of Confidential ’s Pharmaceutical products.
• Take corrective action where/when necessary. Perform in a Customer Advocacy role. Monitor Customer Satisfaction.
• Managed complaint response and required corrective actions are performed in accordance wif US, and other regional regulations and directives.
• Responsible for reporting adverse events to regulatory bodies, preparing FDA - MedWatch Reports.
• Execute recall and field action activities where required or as directed.
• Responsible for administering and for process improvement initiatives of one or more QA subsystems (e.g., DCN, CAPA, NCR, and PDR) as assigned.
• Performed analysis of complaint and survey data; summarize the data, and clearly report findings, conclusions and recommendations.
• Coordinated wif other departmental for records such as, Stability Data, Certificate of Analysis, and Labeling. Request QC Laboratory to test all Complaint samples, and Retention Samples as per related to complaint.
• Performed Complaint Quarterly and Annual Reports, Status Reports, per Complaint and Bi-Weekly Trending Reports.