Resume Regulatory Project Consultant - Hire IT People

SUMMARY:

18 years as a Regulatory Project Consultant within the Biotech, Pharmaceutical, and Medical Devices
Strategic management skills and ability to Analyze, Plan, Implement and Execute - Corporate Strategies
Industry and Competitor analysis of Products, Suppliers, Customers, Emerging Technology, Regulatory
Understanding of product development strategies of Disruptive and Sustaining product technologies
Experience with Drugs - Small Molecule, Biologics - Protein Therapeutics, and Medical Devices
Ability to lead or assist in the development of Integrated Strategy including, Regulatory Strategies, Clinical Development Strategies, Legal and IP Strategies, R&D Strategies, Quality and Process Management, Marketing Strategies, Competitor and Industry Strategies, and Global Integrated Regulatory and Commercialization Strategies
Support executive management with the implementation of organizational wide regulatory requirements
Thorough knowledge of Confidential Regulations, ICH Standards, European Medicines Agency (EMA), Japanese Pharmaceutical and Medical Devices Agency (PMDA)
Full Product Lifecycle experience across R&D, Pre-Clinical - GLP, Clinical - GCP, Manufacturing - cGMP
Experience developing detailed project plans and work schedules to meet Confidential regulatory requirements
Demonstrated success in driving change and continuous process improvement in support of global operations
Successfully led high-performance teams with a demonstrated success solving complex business and regulatory challenges.
Solid experience as a consultant developing clinical trial processes and systems, and clinical research operations, and implementation of protein therapeutic manufacturing systems and processes.
Experience with managing regulatory scope through tight controls and procedures
Experience with monitoring project costs to ensure budget adherence
Business and regulatory process analysis and implementation

PROFESSIONAL EXPERIENCE:

Confidential

Regulatory Project Consultant

Responsibilities:

Strong verbal and written communication skills
The ability to manage multiple large projects of diverse scope across functional areas or multiple products
Attention to detail and expertise using structured PM methodologies processes and tools.
Experience w/ MS Project Professional, MS Office Suite and Visio
Excellent facilitation, planning, organizational, and coordination skills.
Effective conflict resolution skills. Assertive enough to focus and lead projects, but who is not too aggressive
Relationship builder - polite, collegial and professional
Ability to meet the budget and schedule for the project, as well as manage the project plan
Experience with coordinating the Project Management responsibilities for related initiatives to manage cross-project dependencies
Experience with issue resolution and appropriate issue escalation
Experience with managing for gaps, issues, and risks
Able to document and lead lessons learned following project completion and shares results with management
Able to provide team leadership and team building

Confidential

Regulatory Project Consultant

Responsibilities:

Experience with performing quality audit reviews and escalating project issues as appropriate
Experience with working with the QA teams to ensure that compliance requirements are met
Developed and implemented policies, business processes and SOP’s related to FDA, NIH, and DHHS regulatory requirements
Responsible for the oversight and implementation of GCP regulatory requirements for clinical studies involving human subjects
Responded to regulatory audits and inspections, and responding to 483 observations and Warning Letters and then implemented and oversaw any Corrective Action Preventative Action (CAPA) plans
Responsibilities for implementing new business processes and improving existing operations related to GCP and GLP practices
Reviewed and implemented GCP requirements related to HIPAA and HITECH regulations
Performed audits and reviewed existing practices and procedures related to Protected Health Information (PHI) and privacy requirements
Confidential validation experience (IQ, OQ, PQ) with instrumentation, clinical and manufacturing systems
Assisted the animal care staff with interpreting and implementing USDA animal welfare regulatory requirements
Reviewed and assisted with the implementation and application of IACUC requirements

Confidential

Regulatory Project Consultant

Responsibilities:

Strong understanding of GLPs, GCPs, cGMPs, QSRs, Quality Management Systems
Understanding of eCTD, eTMF, SPL
Understanding HIPAA and HITECH regulations, ITAR and Export Control
Comprehensive understanding of Confidential Regulations 21 CFR Parts 11, 46, 50, 54, 56, 58, 201, 210, 312, 314, 320, 511, 807, 812, 814, 820, 860 and Bioresearch Monitoring Program (BIMO)
European Union Commission Annex 11, Annex 15, ISO 9001, ISO 13485
International Conference on Harmonization (ICH) Standards
Familiar with Confidential guidance documents, but may need to review specific guidance’s related to project requirements

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