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Director of Regulatory

4 months ago

Kennesaw, Georgia, United States Archer Daniels Midland Company (ADM) Full time
Director Regulatory & Scientific Affairs, Health & Wellness - North America
This is an Exempt level position.

Position Summary:
The Director Regulatory & Scientific Affairs, Health & Wellness - North America 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, the Senior Director H&W RSA Compliance and Technical Operations and the 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 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 Senior RSA H&W NA Manager, 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.
Required Skills:
  • Ability to manage multiple projects and prioritize workload.
  • Highly organized and able to work according to strict deadlines
  • Strong problem-solving and decision-making skills
  • Ability to develop and leveraging networks within various stakeholders (internally and externally).
Education Requirements:
  • Technical/scientific studies: Degree in Food technology or law, Chemistry, Biology or Biochemistry.
  • Professional level capability in English
  • Knowledge of relevant regulations and standards for the food industry
Required Experience:
  • Minimum of 5 years of experience in a regulatory role, in US within the dietary supplements industry.
Desired Experience:
  • Experience in Food and Beverage (Desirable).
  • Experience in a regulatory role in Canada, within the dietary supplements industry is a plus.
  • Cross-functional experience in the dietary supplements industry is a plus.
Excited about this role but don't meet every requirement listed? Studies show that often applicants will self-select out if they don't check every box. 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:85105BR