Position: Regulatory Affairs Manager
Reports to: EVP Business Development
Position Purpose: Oversees the domestic and international regulatory (phytosanitary) and or import/export permitting and approval process required for the transportation of plant materials from and into the US into various countries around the world. The role also requires filing necessary applications and handling all regulatory interactions with government or quasi-government organizations, coordinating inspection of our facilities, and develops procedures to ensure regulatory compliance.
- Prepare and coordinate regulatory submissions (including agencies, attorneys, data protection authorities, etc.).
- Provide responses to regulatory agencies regarding product information or issues.
- Review company practices; provide advice and determine what changes are required to comply with existing and new regulatory requirements.
- Maintain expertise on regulatory requirements, trends, and developments that pertain to domestic and international movement of plant materials. Keep team leaders/members abreast of regulatory changes and work with cross-country teams to develop viable solutions that meet the appropriate regulations.
- Manage and maintain all regulatory documents, database entries, protocols, etc.
- Work with operations to prepare for and facilitate inspections and audits by regulatory agencies and/or clients. Oversee compliance with standard operating procedures to ensure compliance with applicable standards and regulations.
- Prepare and present department-specific and companywide training for new and existing regulatory requirements. Train staff in regulatory policies or procedures.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Master’s degree or the equivalent combination of education, training, or work experience
- 10 years of experience as an individual contributor in Regulatory Affairs
- Excellent attention to detail
- Considerable understanding of both legal and scientific matters
- An understanding of government processes and procedures
- Excellent reading comprehension and presentation skills
- Commercial and financial acumen with a full understanding of the impact of failure in terms of business cost, production schedules, and customer order fulfillment
- Strong analytical and problem-solving skills
- Results oriented and organized with the ability to plan and deliver against deadlines
- Fluency in Spanish preferred
- 1 to 3 years supervisory experience preferred
To apply, submit a cover letter and resume to firstname.lastname@example.org