Gerente de Assuntos Regulatórios

Overview:
Under limited supervision, this position will be responsible for assisting the sales team in LATAM with all the regulatory and technical questions related to Kemin Health products. This position should be based in Brazil, in Sao Paulo preferably and will work jointly with the sales team and Kemin customers and distributors to open the regulatory barriers in the LATAM countries defined as being a priority for the region. This includes without being limited to Brazil, Mexico, Colombia, Peru, Chile, Argentina. In addition to establishing the regulatory status of Kemin Health product and answering customers technical questions with the support of the US team, this position will be "customer facing" which implies regular physical and virtual visits to customer in the region. Additionally, this position requires the ability to provide a regulatory analysis on food ingredients and their components (raw materials, processing aids) including contaminants limits for KH products and product in PIP (Product Innovation Process). Maintenance of the existing regulatory submissions as well as preparation of new dossier are also part of this position scope. Lastly, they will accurately populate and maintain the databases and trackers in real time. May represent Regulatory Affairs on project teams, as more experience is acquired.
EDUCATION
- Bachelor's degree in a scientific background with 3-5 years related experience preferred.
- Master's Degree is a plus. Degree should be in Pharmacy or food sciences and technologies
**Responsibilities**:
ESSENTIAL FUNCTIONS:
- Assist the sales team and KH LATAM customers with all the technical and regulatory questions related to KH products
- Ensure regulatory compliance for Kemin products
- Monitor new legislation in all the LATAM region and maintain KH Regulatory team updated on all new legislation potentially affecting KH product.
- Represent Kemin in ABIAD and other trade associations if needed
- Actively participate to the establishment of regulatory strategies for KH current or future products in the regions
- Assist with the product registrations on a timely basis
- Jointly with the TSM team, monitor the scientific data supporting KH products and prepare the technical material needed for the customer visits
- Assist the RA Team in the US with the development of the labels and other product documentation related to the LATAM region
- Be the regulatory contact for risk assessments of raw materials and new products in PIP
- Prepare registration dossiers, amendments, monthly reports, and supplements for submissions to regulatory authorities with limited supervision.
- Under limited supervision, may represent Regulatory Affairs on team projects, as they gain knowledge.
- Understand regulatory requirements and relevant government regulations in the region, as well as stay current on regulatory issues affecting Kemin products in these countries.
- Evaluate and research any submission deficiencies, additional information or testing as requested by regulatory authorities
- Follows and maintains an environment of food safety in compliance with rules and regulations, as applicable.
OTHER FUNCTIONS:
- Other duties as assigned to support the IPRA team.
ESSENTIAL SKILLS & EXPERIENCES:
- Extensive knowledge of MS Excel, Word, and PowerPoint software.
- Fluency in Spanish, Portuguese and English is required (additional language(s) is a plus).
- Familiarity with regulations in the region is a must.
- Excellent attention to detail required, reliable, highly motivated, ability to work independently and interacts well in a team environment.
- Possess excellent verbal, written and interpersonal communication skills, demonstrated good technical writing skills, ability to present ideas effectively.
- Excellent organizational and time management skills, demonstrated prioritizing, planning and project management skills.
- Experience in reviewing and evaluating scientific literature with demonstrated ability to analyze and assemble/synthesize scientific information from many sources, including identification of information gaps and future research needs.
**TRAVEL**:Up to 25% travel.
Qualifications:
LI-TC1

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