Director of Regulatory & Scientific Affairs, Health & Wellness

Archer Daniels Midland

Director of Regulatory & Scientific Affairs, Health & Wellness - Based on-site at any ADM location in the US, including Kennesaw, GA, Decatur, IL, Erlanger, KY, Chicago, IL

Summary:
This role is responsible for providing local technical support for the definition and execution of the commercial strategy in North America. This role works in conjunction with the Global RSA H&W Head, and the cross-functional H&W team to leverage regulatory compliance of the H&W portfolio by leading the assessments of permissibility and suitability in North America (NA) and any registration or process associated, to unlock the market according to the business strategy.

Job purpose:

North America Regulatory and Scientific Affairs responsibility for ADM Health & Wellness (H&W) microbiome-based food supplements and other health-regulated ingredients.
Drive cross-functional collaboration, proactive regulatory risk management and mitigation while informing innovation and enabling market access and business growth.
Engaging and aligning with commercial partners to develop and implement regulatory strategies that enable ADM H&W business.

Responsibilities:

Own the gap analysis of Health & Wellness portfolio against regulatory requirements and other relevant guidelines, providing subsequent advice to relevant colleagues in order to develop the data to unlock the NA market according to the business strategy.
Lead and support the assessment and approval of the steps that require regulatory input and are related to innovation and/or permissibility and suitability of the H&W portfolio.
According to the metrics and KPIs established by H&W and RSA, own trending and root cause analysis of NA’s KPIs and implements actions to ensure a positive trend according to H&W expectations and ADM policies and standards.
Lead regulatory feedback on topics related to claims and marketing materials intended for North America.
Own the Regulatory Risk Assessments related to the permissibility and suitability assessments of the H&W portfolio intended for North America, according to the current process and propose technical mitigation actions as applicable.
Own the preparation, review and submission of regulatory dossiers and applications for the H&W portfolio in North America and ensure accuracy, completeness and compliance with regulatory requirements in close collaboration with internal SMEs and external experts.
Works in conjunction with the global RSA team, as well as local ADM country colleagues to achieve new products authorizations, renewals and successful variations of H&W products manufactured in North America.
In conjunction with the Global RSA H&W Head, ensures regulatory compliance for ingredients and products throughout their lifecycle.
Leverage the regulatory service ADM provides to its customers in accordance with ADM policies and processes by representing RSA H&W in meetings with key customers and by leading the H&W RSA team responsible for North America.
Keep abreast of regulatory requirements, guidelines and industry best practices related to H&W ingredients and make strategic recommendations to senior management as risks and opportunities arise.
Ensure alignment and engagement of the NA H&W RSA teams, using common ways of working, for daily interactions of RSA and business/client stakeholders within the region.
In conjunction with relevant RSA colleagues, develops and manages regulatory positions by writing and reviewing regulatory documents (SOPs, Work Instructions, RSA statements and guidelines) according to the Document Management System.
Ensure North America RSA H&W team members are adequately resourced to serve the commercial and technical needs of business stakeholders regarding the H&W product portfolio and daily operations.
Ensure alignment and engagement of the NA H&W RSA teams, using common ways of working, for daily interactions of RSA and business/client stakeholders within the region.

Qualification and Experience:

Degree in Food technology or law, Chemistry, Biology or Biochemistry
10+ years of experience in regulatory affairs within food supplements, health ingredients, and/or microbiome ingredients.
Proven experience managing complex regulatory submissions,
Knowledge of relevant regulations and standards for the food industry.
Strong understanding of US and Canada regulatory frameworks.
Experience in regulatory advocacy and industry representation desirable.
Strong organizational, attention to detail, communication, and strategic planning skills, with ability to operate cross-functionally and at various levels of the organization.
Hands-on experience with regulatory systems, RIMS, and documentation platforms is a plus.

Excited about this role but don’t think you meet every requirement listed? We encourage you to apply anyway. You may be just the right candidate for this role or another one of our openings.

ADM requires the successful completion of a background check.

REF:111352BR

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