Open to opportunities

Joseph Livingston

@josephlivingston

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Performance-driven regulatory affairs leader with over 10 years of experience.

United States

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What I'm looking for

I am looking for a role that offers opportunities for leadership and strategic influence in regulatory affairs, with a focus on collaboration and innovation.

I am a performance-driven regulatory affairs and quality leader with over 10 years of experience in regulated environments. My expertise lies in designing and executing regional and global regulatory strategies that consistently reduce time-to-market. I pride myself on being a reliable and detail-oriented team player, equipped with strong interpersonal and communication skills. Throughout my career, I have made significant contributions to product safety, quality management, project management, and process improvement.

Currently, I serve as the Senior Regional Manager for Regulatory Affairs at Abbott Molecular, where I set regulatory strategies and direct submissions to regulatory agencies. I lead cross-functional teams and represent the International Regulatory Affairs function in high-level interactions. My previous roles have included managing regulatory activities for Latin America and Canada, where I successfully implemented regulatory intelligence frameworks and streamlined processes through a Regulatory Information Management system.

My educational background includes a Bachelor of Pharmacy from Universidad del Atlántico in Colombia. I am passionate about ensuring compliance and driving strategic enhancements in regulatory processes, and I am committed to fostering collaboration among teams to achieve business objectives.

Experience

Work history, roles, and key accomplishments

Current

Sr Regional Manager Regulatory Affairs – EMEA/ LAC

Current

Abbott Molecular Inc.

May 2024 - Present (1 year 1 month)

Set regulatory affairs strategies and directed the preparation of submissions for products to regulatory agencies, interfacing with agencies to obtain timely approval for new products. Monitored the external environment for evolving policies impacting product development, collaborating with Subject Matter Experts to analyze impact and plan strategy.

Regulatory Affairs Regulatory Strategy Product Development Regulatory Submissions Strategic Planning

Regional Manager Regulatory Affairs – EMEA

Abbott Molecular Inc.

Jan 2023 - Present (2 years 5 months)

Provided leadership in regulatory activities for the assigned region, including developing regulatory strategies, leading submissions, and managing critical health authority interactions. Led the development of regulatory intelligence frameworks and processes to integrate relevant insights into decision-making, ensuring the company stayed ahead of regulatory changes.

Regulatory Strategy Regulatory Intelligence Process Improvement

Regional Regulatory Project Manager – Latin America & Canada

Abbott Core Diagnostics

Aug 2021 - Present (3 years 10 months)

Led the development and implementation of regional strategy for projects, ensuring alignment with business objectives and overseeing Health Authority submissions and approvals. Coordinated risk identification for projects and submissions, implementing mitigation strategies and managing issues to closure.

Project Management Regulatory Strategy Risk Management

Regulatory Affairs and Quality Assurance Manager – Colombia

Abbott Core Diagnostics

Jan 2019 - Present (6 years 5 months)

Ensured regulatory compliance with pre- and post-approval filing and reporting requirements, monitoring the local regulatory environment to provide updates to business partners. Supervised daily activities involved in product release, purchasing controls, CAPA, document control, training, and risk management to ensure compliance with quality standards.

Regulatory Compliance Quality Assurance CAPA Document Management Risk Management

Regulatory Affairs Leader

General Electric Healthcare

May 2017 - Present (8 years 1 month)

Assessed regulatory pathways for new products and modifications, developing and executing regulatory strategies for submissions in assigned markets. Led regulatory compliance activities for post-market vigilance reporting and product recalls.

Regulatory Pathways Regulatory Strategy

Americas Hub CMC Regulatory Coordinator

Pfizer Consumer Healthcare

Oct 2015 - Present (9 years 8 months)

Developed and led the execution of regulatory strategies supporting global development and life cycle management of assigned projects. Managed the authoring, review, and approval of CMC data packages for regulatory dossiers of global marketing applications and post-approval life cycle activities.

Regulatory Strategy Global Development Manufacturing Changes Quality Assurance

Regulatory Affairs Specialist

Johnson & Johnson

Sep 2013 - Present (11 years 9 months)

Assessed regulatory pathways for new product platforms and modifications, developing and executing regulatory strategies for submissions in assigned markets. Reviewed and approved advertising and promotional material to ensure consistency with approved claims and regulatory requirements.

Regulatory Pathways Regulatory Strategy Advertising Regulatory Compliance

Education

Degrees, certifications, and relevant coursework

Universidad del Atlántico

Bachelor of Pharmacy, Pharmacy

Completed a comprehensive curriculum in pharmacy, gaining foundational knowledge in pharmaceutical sciences. Developed skills in regulatory affairs and quality management relevant to the healthcare industry.