LATAM Regulatory Compliance Sr. Analyst
About this role:
Responsible to ensure that the Quality Assurance compliance strategy is consistently implemented in support of the commercial teams. Assures, together with relevant functions, early and effective regulatory compliance assessments for new and existing ingredients and formulations leading to compliance by design of ingredients, labels, and communications. This role supports the entire Tate and Lyle business and Industrial partners. Proactively engages with Quality, Applications, ICD, EHS, and other relevant internal stakeholders as well as, with authorities, associations and other external stakeholders as appropriate. Ensure Compliance related programs are appropriately managed and enforced.
Accountabilities:
Verification of compliance to global regulatory standards for all products, including co-products
Develop regulatory assessments as required for new and existing ingredients, raw materials, processing aids, chemicals, packaging and formulations. Identify potential compliance risks and recommend mitigation strategies.
Verification of compliance to regional regulatory standards for new raw materials, processing aids, chemicals, or packaging for production during Q-MOC process – via the Decernis (applicable) software package.
Regulatory Compliance approval of product ingredient statements and any associated allergen warnings
In support of Technical Quality (TQ) provide Basic Regulatory guidance regarding customer questions (e.g. nutritional, GMO, vegan, organic, etc.) for all T&L products; includes the coordination with Regulatory & Scientific Affairs staff the annual review of standard regulatory type letters distributed by TQ.
Supporting TQ by providing basic regulatory compliance guidance related to nutritional labeling changes, product claims (i.e. gluten-free, low gluten, organic), product weight controls all T&L products.
Analyze and identify emerging regulatory topics from customer requests to suggest and prepare standard replies
With the guidance of the regional Regulatory Affairs team, support regional site regulatory inspections and findings/corrective actions; provide guidance as needed.
Investigate compliance violations and recommend corrective actions
Issue Management: Fast and reliable issue resolution (corrective and preventive processes and actions) in area of responsibility; brief senior leadership as needed.
Manage programs required to meet Regulatory requirements such as FDA Registration, FDA Certifications, Non-GMO, FSVP program, REACH, DMF – Drug Master File submissions etc. including the preparation, support, and coordination of TL related certifications, submissions, registrations, licenses and documentation.
GSQM support in region.
Skills and Experience:
Fluent in English and Porteugese. Ability to read Spanish a plus.
Requires BS/BA, in Chemistry, Regulatory Affairs, Legal, toxicology and/or food science or another compliance field. Advanced graduate degree will also be considered.
Good knowledge of Microsoft Office programs, Sharepoint, ERP (SAP), etc.
Cosmetic/Pharma knowledge preferred in addition to Food/Feed knowledge requirement.
Knowledge of major regulatory agencies such as, the US/EU/Brazil/China or other significant Food, Feed, and industrial regulations; knowledge of multiple markets is an asset.
Good knowledge of food chemistry and food ingredient technology or CPG industry
Knowledge of packaging regulations and application to compliance.
5+ years’ experience in the food industry, or associated industries (specialty chemical, nutritional supplements, pharma (excipients), cosmetics etc.) primarily in regulatory affairs, regulatory compliance, quality, nutrition, or product development, with significant direct experience with FDA, USDA, AMVISA, or like.
Acts decisively and ahead of issues and anticipates for the long term.
Experience in effective networking across functional boundaries and externally.
Enhances overall department effectiveness by encouraging team working behaviors across boundaries; work coordinated with team partner globally.
Strong written & verbal communication skills, including influencing & negotiation skills, and an ability to communicate regulatory & technical issues in laymen’s terms.
Ability to build process flows and RACI’s related to area of support.
Trusts his/her own capacity to face critical situations and is ready to face any challenge.
Keeps all relevant people informed to improve team effectiveness and leads the team to success.
Supports others in their development and creates a positive environment for long term development and growth.
Gives a personal and original view to solve a problem, explain a given situation or create an opportunity.
Tate & Lyle is an equal opportunity employer, committed to the strength of an inclusive workforce.