Regulatory Compliance Senior Associate

INTRODUCTION

Detail-driven multi-industry Regulatory Compliance Program Director with advanced degree and PMP certification focused on maximizing company compliance with applicable global laws and standards in some of the most challenging government and industrial regulatory environments for some of the largest global organizations. Demonstrated ability to research and initiate global multi-industry best practices and regulatory changes to support business initiatives, facilitate compliant corporate legal governance, and maximize revenues. Especially interested in taking on the challenges of nuclear and/or pharmaceutical / biotechnology industry regulatory compliance with an outstanding ability to conduct research and a desire to learn.

SKILLS

Auditing

Training

Assigning roles and responsibilities

Testing

Developing policies

Measuring

Documenting

Reporting

SIGNIFICANT ACHIEVEMENTS

Regulatory Compliance Consultant – Department of Energy Complex 10/1988-12/2023

Demonstrated leadership in regulatory submissions and compliance, risk management, process improvement, corporate governance, leadership, development, assessment, management.

Responsible for building, growing, and managing a comprehensive compliance department and programs, ensuring alignment with regulatory mandates, and supporting strategic mission initiatives.

Applied project management methodologies for planning, scheduling, budgeting, engineering.

Collaborated with senior management to create comprehensive data analyses, then generated reports detailing compliance, while reducing required staff and increasing throughput by 35%.

Conducted continuous research to remain current with evolving regulatory requirements.

Coordinated and interfaced with design engineers to ensure changes meet regulatory requirements.

Created, implemented, tracked, and maintained timely organizational policies and standards.

Effectively interfaced with the regulator from a regulatory, planning, and budget perspective.

Ensured that documents submitted to regulatory agencies are complete, well organized, accurate.

Prepared and delivered compliance presentations to internal and external organizations.

Provided oversight and insight regarding regulatory changes, trends, areas for potential risk and process gaps and developed plans, policies, solutions to address each.

Knowledge of manufacturing processes associated with drugs and biologics.

EDUCATION / CERTIFICATION

Ph.D. Candidate - Organizational Management, Capella University

M.Sc. - Information Technology, Capella University

PMP - Project Management Professional (PMP) Certification

DECLARATIONS

U.S. Citizen. Valid driver’s license. Male. Caucasian. Fluent in English. Beginner Spanish and German. Able to pass a criminal background check and pre-employment and periodic drug tests. No disabilities past or present. Covid-19 vaccinated. Veteran, non-protected. Open to occasional travel.

https://www.linkedin.com/in/david-eikelberg-571652a0/

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