Position Summary

The Senior Manager / Director of Global Product Regulatory Affairs is responsible for ensuring that all products are fully compliant, properly registered, and operationally ready for seamless global distribution. This role is specifically focused on product regulatory execution (formulations, claims, labeling, registrations, and documentation) and does not include legal or commercial regulatory responsibilities.

This leader owns the end-to-end regulatory process, from early-stage formulation review through market entry and ongoing compliance, across all international markets.

This role demands urgency, precision, and accountability to ensure regulatory readiness doesn't slow commercial execution. The ideal candidate brings deep expertise in global product regulations, strong cross-functional leadership, and the ability to build scalable, high-performance processes that consistently deliver on time.

Key Responsibilities

Global Regulatory Strategy & Execution

• Lead regulatory strategy for new product launches across all global markets (EU, APAC, LATAM, North America), ensuring timely registrations and approvals aligned to commercial deadlines
• Conduct early-stage regulatory evaluations of formulations and ingredients in close collaboration with Product Development and international market teams to ensure global viability before development is finalized
• Proactively identify and resolve potential regulatory risks early in the innovation process to avoid downstream delays, reformulations, or market exclusions
• Own end-to-end regulatory readiness, including labeling, claims substantiation, documentation, and compliance requirements
• Ensure all products are fully prepared for international shipment, including customs documentation and import/export compliance, with zero tolerance for preventable delays

Proactive Timeline Management & Operational Excellence

• Establish and actively manage regulatory timelines with a proactive, forward-looking approach-anticipating risks and preventing delays before they occur
• Drive urgency and discipline across all regulatory activities, with a clear expectation of on-time, first-pass execution
• Identify and eliminate bottlenecks, while continuously innovating to reduce product registration timelines without compromising compliance
• Build a culture that resists complacency and consistently raises the bar on speed, accuracy, and accountability

Cross-Functional & Global Collaboration (CRITICAL)

• Partner closely with the Cross-Functional Innovation Team, Regional Product Management, International Regulatory team members, and shipping/logistics partners to ensure seamless execution from product registration through final delivery
• Ensure products are not only approved, but physically delivered, cleared through customs, and received into market warehouses on time and ready for sale against project deadlines
• Serve as the central point of coordination to align regulatory, supply chain, and market teams around shared timelines and execution standards

Global Compliance & Risk Management

• Maintain deep expertise in key regulatory environments, including EU, FDA, APAC, and LATAM markets, and ensure team members do as well
• Monitor and interpret evolving regulations, ensuring the organization remains compliant and ahead of changes
• Lead rapid issue resolution when regulatory or customs challenges arise, minimizing business impact

Process Improvement & Team Leadership

• Conduct rigorous post-mortems on delays or failures to identify root causes and implement durable fixes
• Build and lead a high-performing regulatory organization with clear ownership, accountability, and performance expectations
• Introduce tools, systems, and best practices to scale global regulatory operations efficiently

Qualifications

• Bachelor's degree required; advanced degree (Regulatory Affairs, Life Sciences, or related field) preferred
• 8–12+ years of experience in global product regulatory affairs within dietary supplements, pharmaceuticals, or related industries
• Demonstrated expertise in EU, APAC, LATAM, and FDA regulatory frameworks
• Proven track record of successfully managing global product registrations and launches
• Strong understanding of customs requirements, import/export regulations, and documentation standards
• Experience building or transforming regulatory processes and teams

Key Competencies

• Relentless Ownership: Takes full accountability for outcomes end-to-end, including downstream impacts (e.g., shipments, customs clearance, market readiness)
• Sense of Urgency: Operates with speed and intensity; does not allow timelines to drift
• Proactive Execution: Anticipates issues early and acts decisively to prevent delays
• Continuous Improvement Mindset: Challenges the status quo and actively reduces cycle times and inefficiencies
• Cross-Functional Orchestration: Effectively aligns regulatory, product, and logistics teams to deliver on committed timelines

Success Metrics

• On-time, first-pass approval of product registrations across the EU, APAC, LATAM, and North America
• Zero shipment delays due to regulatory or documentation failures
• Products consistently delivered, customs-cleared, and received into market warehouses on or ahead of launch deadlines
• Measurable reduction in regulatory cycle times year-over-year
• Early-stage regulatory alignment resulting in minimal reformulation or late-stage market exclusions
• High satisfaction and trust from OBU leadership and international colleagues

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