Regulatory Affairs Expert

rovensa•White Eyes Township, OH

5d•Remote

About The Position

Rovensa Next is the Rovensa Group’s global business unit, specialising in biosolutions for agriculture. It is made up of twelve pioneering Rovensa Group companies: Agrichembio, Agro-K, Agrotecnología, Cosmocel, Idai Nature, Microquimica, MIP Agro, Oro Agri, OGT, Rodel, SDP and Tradecorp, with a consolidated background in sustainable crop nutrition and biocontrol management. Rovensa Next combines local technical knowledge, innovation and teams that work alongside farmers and distributors in the field to solve their sustainability challenges, backed by the global expertise and leadership of the Rovensa Group. It is aimed to shape a sustainable future for agriculture and drive its biotransformation. When you join Rovensa Next you are not just joining a dynamic team of people gearing up to create a sustainable future – you are joining a team that is intent on making it a reality. Let’s grow greener! www.rovensanext.com/ Our mission: You will be driving regulatory activities to ensure compliance and market access of Rovensa Next portfolio (biocontrol, bionutritional and biostimulant products) within the North America region.

Requirements

Requires a Bachelor’s degree in relevant scientific discipline (biological science, chemistry, or toxicology etc.). Master’s degree is highly preferred.
5 years proven professional experience in a similar agrochemical regulatory environment.
Excellent knowledge of regulatory requirements for agricultural crop remedies, including nutrition, bio-stimulants, bio-pesticides and/or adjuvants.
Basic knowledge of import, export and transport regulations including DOT, IMDG, IATA, EPA, TSCA, FDA, and USDA.
Experience with interpreting technical material such as trial and toxicology reports.
Ability to work independently and in a team environment.
Analytical person with creative and strategic thinking.

Responsibilities

Prepare, submit and maintain product registration dossiers, labels and related activities in North America
Develop and implement registration submission strategy to achieve commercial objectives including advising various departments of data requirements to support product registrations.
Create, coordinate and review product technical documents such as labels, supporting literature, and registration dossiers.
Ensure that Rovensa Next product labelling, classification and sales comply with local regulations, provide relevant risk analysis in the region and initiate corrective measures when needed.
Evaluate and advise on raw materials, formula changes, monitor product conformity, compliance and assist with internal audits requiring regulatory input.
Contract and monitor third part laboratory studies (e.g., acute toxicity, agricultural residues, heavy metals) as needed to support regional product registrations. Conduct scientific data review.
Liaise and co-operate with global regulatory team for product registrations and special projects.
Identify, troubleshoot, and increase efficiency in areas of improvement/potential problems and development of policies and procedures to meet regulations and requirements.
Keep up-to-date knowledge of local regulations: national regulations on fertilizers, biostimulants, plant protection products, organic farming standards, other horizontal regulations and their trends.
Performs other related tasks as assigned.