Sr. Director, Global Regulatory Affairs

Plexus Worldwide•Scottsdale, AZ

About The Position

The Senior Director of Regulatory Affairs leads Plexus’ global regulatory and quality strategy, championing compliance while unlocking product innovation and international expansion. This role partners cross-functionally to support business growth, accelerate market entry, and maintain best-in-class product quality and regulatory excellence across all markets. This is a high visibility role with direct impact on company growth and product innovation, offering the opportunity to lead global expansion into new and emerging international markets, build and modernize regulatory infrastructure, including QMS and AI-enabled tools, and shape strategy, processes, and team capabilities in a dynamic environment where you are doing new things in new markets.

Requirements

Bachelor’s degree in Chemistry, Biology, or related scientific field (or equivalent experience)
8+ years of progressive regulatory experience in dietary supplements, food, cosmetics, or OTC products, including international markets
5+ years of leadership experience managing regulatory teams (10+ years preferred in team leadership environments)
Strong knowledge of U.S. regulatory and quality requirements, including 21 CFR Parts 111 and 117, and global regulatory frameworks
Experience managing regulatory submissions, labeling, and approvals across key international markets (e.g., US, Canada, Mexico, Australia, Korea, Japan, Brazil, Germany, UK)
Deep understanding of product development, formulation, claims substantiation, and compliant marketing practices
Proven ability to implement regulatory and quality systems, processes, or tools (e.g., QMS, automation, AI-enabled solutions)
Strong analytical, problem-solving, and decision-making skills with the ability to interpret scientific and regulatory data
Excellent communication and stakeholder management skills, with experience influencing cross-functional teams and executive leadership
Ability to manage multiple priorities, navigate ambiguity, and operate effectively in a fast-paced, growth-oriented environment
Experience working with regulatory agencies, auditors, consultants, and trade organizations

Responsibilities

Develop and execute global regulatory strategies and roadmaps that are created to align with market trends, legislation, product marketing objectives, and stay current on evolving regulations to advise senior leadership on strategic decisions.
Ensure compliance with U.S. and international regulations across dietary supplements, foods, cosmetics, and OTC products.
Serve as primary liaison with FDA, international agencies, and auditors, including leading meetings and negotiations.
Lead cross-functional review and approval of product formulations for international market expansion, assessing regulatory compliance, ingredient permissibility, and labeling requirements by country; identify and validate acceptable alternative ingredients to ensure continuity of supply while maintaining product integrity and compliance with local regulations.
Partner with International, Operations, Sales, and Marketing to accelerate product approvals and market entry timelines.
Monitor evolving global regulations and proactively guide business decisions.
Provide regulatory guidance early in the product development lifecycle.
Review and approve product claims, labeling, and marketing materials.
Maintain international substantiation for all product claims.
Implement and optimize a Quality Management System (QMS).
Drive adoption of AI-supported regulatory tools and process improvements.
Establish efficient workflows for regulatory reviews, labeling, and submissions.
Lead, mentor, and develop high-performing regulatory and quality teams.
Foster a culture of accountability, collaboration, and continuous improvement.
Provide regulatory and quality training and insights across the organization.
Build strong relationships with executive leadership and key stakeholders.
Influence decision-making to ensure compliant innovation and market readiness.
Support organizational change and scalability through regulatory and quality excellence.