The RolePlexus Worldwide is seeking a Manager, Global Regulatory Affairs to lead the regulatory strategy and execution that bring compliant products to market and keep them there. You will guide product development, claims, labeling, registrations, and market expansion while leading a team of regulatory professionals. This role partners closely with Research and Development, Marketing, Sales, Supply Chain, Quality, Legal, and Compliance.
Employee Value PropositionHelp shape how Plexus grows across global markets. Your work will reduce regulatory delays and rework, protect market access, and help teams launch products with confidence.
Key Performance Objectives- Establish a global regulatory strategy that gives teams clear guidance on product requirements, claims, labeling, and registrations.
- Enable market expansion by developing regulatory plans for launches in Canada, Mexico, Australia, and other priority markets.
- Deliver coordinated launches by identifying regulatory requirements early, managing submissions and milestones, and resolving risks before they delay execution.
- Build an effective regulatory team with clear priorities, consistent processes, and the capability to support multiple markets.
Performance AccountabilitiesGlobal strategy and market execution- Develop regulatory strategies for new products, product changes, and market entry, including classification, formulation, claims, labeling, and registration requirements.
- Partner with cross-functional teams early in development to support commercially viable products and limit market-specific rework.
- Create and manage regulatory plans for simultaneous product launches across multiple markets.
Regulatory oversight and risk management- Oversee product registrations, notifications, licenses, import submissions, and ongoing regulatory commitments.
- Review product labeling and claims, interpret local and international requirements, and provide practical guidance on complex regulatory issues.
- Monitor regulatory changes, assess business impacts, and coordinate responses that protect compliance and market access.
Projects, partnerships, and team leadership- Set priorities, milestones, and ownership for regulatory projects; track progress and escalate risks to leadership.
- Build effective relationships with internal teams, consultants, legal partners, industry groups, and government agencies.
- Lead, coach, and develop regulatory professionals while improving departmental processes, documentation, and tools.
Performance Qualifications- Regulatory expertise: At least five years of regulatory affairs or related experience, with the ability to interpret requirements for products, ingredients, claims, labeling, registrations, and market access.
- Global execution: Experience developing regulatory plans, managing submissions, and coordinating complex projects across multiple markets and timelines.
- People leadership: At least three years of experience leading teams, with the ability to set priorities, coach regulatory professionals, and build team capabilities. Five years of management experience is preferred.
- Collaboration and communication: Ability to advise cross-functional partners, write and review technical documents, and work effectively with regulatory agencies, consultants, and legal partners.
- Education and tools: Bachelor's degree or equivalent work experience and proficiency in Microsoft Word, Excel, and PowerPoint. A degree in a scientific discipline, direct selling experience, and PMP certification are preferred.
- Flexibility: Ability to work occasional evenings, weekends, or holidays as business needs require.
Benefits- Highly rated and competitive medical plans.
- 401 (k) with company match and immediate vesting.
- 1-on-1, personalized health coaching.
- Many other voluntary benefits.
To learn more about Plexus Worldwide, please review our careers page at www.plexusworldwide.com/careers.
Learn more about our One Plexus culture. Watch this short video to see how our values, people, and purpose come together to make Plexus a great place to grow and make an impact. https://plexusworldwide-1.wistia.com/medias/zhfpm3vi4o.
Thank you for taking the time to apply for an opportunity with our One Plexus team! If you had any issues during the application process, please get in touch with us directly at [redacted].
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