|Type of position
|ISK Biosciences Corporation
|Description of Employer
|ISK Biosciences Corporation (ISKBC) is a subsidiary of Ishihara Sangyo Kaisha, Ltd., a company with a history of discovery and development of new agrochemicals based in Osaka, Japan. ISK Biosciences Corporation is seeking a Development and Regulatory Data Management Specialist, based in Concord, Ohio who would be responsible for supporting the development, project management and regulatory compliance of ISK Biosciences products in the Americas.
|7474 Auburn Road, Suite A, Concord, Ohio 44077
|Description of Location
|25 miles east of Cleveland, Ohio
|To be determined based on experience
|ISK offers a comprehensive benefits package including medical, dental, vision, life, AD&D, 401(k), flexible spending, paid time off, and relocation assistance.
|Closing date of competition
|Date position available
|Description of duties
- Support the development, preparation and submission of regulatory dossiers of required studies and summarized technical information suitable for submission to regulatory authorities in the US, Canada, Mexico, Central and South America.
- Assist in securing and maintaining Federal and State registrations of ISK Biosciences Corporation products in the Americas.
- Assist regulatory managers in monitoring the conduct of studies and development of data to support registration and product stewardship activities in each country.
- Act as a liaison between ISK Biosciences Corporation and regulatory authorities, contract research organizations, international colleagues, and distributors of ISK products regarding regulatory and compliance matters.
- Make presentations on behalf of ISK, providing oral arguments as necessary in negotiations with regulatory authorities and ISK business partners as required.
- Prepare summary documents as appropriateto meet local regulatory needs.
- Develop and maintain in-depth knowledge of ISK products sold in each country.
- Assist in ensuring that the importation and sourcing of ISK agricultural products for sale or research is compliant with the laws and regulations in each country.
- Provide technical support and strategic insight to regulatory colleagues globally to enable ISK to effectively plan and deliver registrations of new products enabling ISK to grow their global business and maximize return on R&D investment.
- Provide written comments to authorities or industry Trade Associations when and where appropriate to further ISK Biosciences Corporation business interests in the Americas.
- Work with international colleagues from various disciplines to identify and recommend optimal registration strategies for assigned projects/products.
- Track the progress of ISK registration activities.
- Travel as required to meet with regulatory authorities, company management and technical consulting.
- Science background in one of more of the following areas: biology, chemistry, toxicology, ecology, agronomy
- Knowledge of GLP and regulatory study requirements
- Experience in project management and making regulatory submissions
- Fluency in English and Spanish is a plus
- Knowledge of US and/or Canadian law governing the registration and use of plant protection products is a plus
Evidence of the above qualifications would typically require a Bachelor of Science Degree with 1-2 years of work experience in the registration of agrochemicals, or in a similar position within the agrochemical industry. Post-graduate education and combination of skills obtained in other work experience might alternatively qualify a candidate with little or no direct experience in registration of agrochemicals. Experience in a contract research organization conducting GLP compliant studies is highly desirable.
|Contact for additional information
|Beth Kase, Manager of Human Resources
|Interested candidates should submit their resume via email to Beth Kase, Manager of Human Resources:
|This position will be based in Concord, OH and the successful candidate would report to the Vice President of Corporate Technology. The ability to work in the USA is required We offer a competitive salary and excellent benefits.