Verdesian Life Sciences is seeking an ideal candidate to fill the role of Regulatory Affairs Manager, North America in the corporate office in Cary, North Carolina.
The Regulatory Affairs Manager provides regulatory oversight for Verdesian Life Sciences products, projects, and technologies. This position supports the commercialization of crop, animal nutrition, and aquaculture products through product registrations, regulatory compliance activities, and global regulatory strategy. The role works closely with cross-functional teams, including Sales, Marketing, R&D, and Business Development, to ensure successful market access and compliance worldwide.
Essential Responsibilities:
- Prepare, review, and submit regulatory filings for assigned projects.
- Support domestic and international product registrations and ongoing compliance activities.
- Review product labels, promotional materials, SDS documents, specifications, and technical data for regulatory compliance.
- Interpret and communicate changing regulatory requirements and their business impact.
- Collaborate with regulatory agencies, consultants, customers, and international regulatory representatives.
- Manage relationships with external regulatory consultants and service providers.
- Advise internal teams regarding regulatory requirements, labeling standards, export requirements, and compliance concerns.
- Develop and improve regulatory systems, processes, and procedures to support global business growth.
- Maintain regulatory records and documentation necessary to obtain and sustain product approvals.
- Investigate product complaints and coordinate appropriate regulatory responses when necessary.
- Participate in industry associations and regulatory forums on behalf of Verdesian Life Sciences.
- Support regulatory projects and other duties as assigned.
Qualifications:
Required
- Bachelor's degree in Agriculture, Animal Nutrition, Biology, Chemistry, or a related scientific discipline; advanced degree preferred.
- Minimum of 5 years of regulatory affairs experience.
- Strong scientific background and understanding of regulatory processes.
- Experience developing and maintaining procedures and documentation.
- Strong organizational, analytical, and communication skills.
- Ability to manage multiple projects and deadlines simultaneously.
- Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.
Required
- Experience with regulatory data generation related to product chemistry, toxicology, ecotoxicology, human exposure, environmental fate, or residue chemistry.
- Experience working within EPA, PMRA, EU, OECD, or similar regulatory frameworks.
- Knowledge of ISO, EU, and OECD standards.
- Bilingual language capabilities.
Verdesian Life Sciences is an equal opportunity employer to all, regardless of age, ancestry, color, disability, military or veteran status, national origin, political affiliation, race, religious creed, sex, and sexual orientation.