Careers
| Job Posting: |
Manager Regulatory Affairs |
|
| Location: |
Melbourne, Florida |
| Status: |
Full time, Exempt Employee |
| Department: |
Product Development |
| Reports to: |
Sr. Director Product Development |
| Education Level: |
Minimum B. S. Degree in applied science or business |
| Base Salary: |
Competitive Salary |
Job Description
Job Function:
The Manager Regulatory Affairs will have the responsibility for managing, coordinating, and directing regulatory activities at TyraTech. S/he will work with the Sr. Director of Product Development within the Commercial department to provide expertise in translating regulatory requirements into practical, workable plans and to implement and manage all regulatory processes in compliance with U.S. Federal and State regulation & registration requirements.
Primary Duties:
- Establish and implement company regulatory processes and systems to ensure compliance with applicable State and Federal regulatory requirements.
- Provide relevant registration strategies for chemicals regulated under FIFRA as well as FIFRA-exempt products regulated by the US Environmental Protection Agency and U. S. State regulatory bodies.
- Provide guidance to TyraTech for all relevant Federal and state legislation governing the development, registration and use of pesticides and pesticide containing products across broad uses in agriculture, horticulture, commercial and industrial pest control, and animal and public health uses.
- Coordinate the preparation of regulatory packages for submission to EPA and State regulatory agencies for exempt and non-exempt product submissions. Following submission, monitor and creatively manage the regulatory process to minimize the time to regulatory approval.
- Provide relevant information and support to global regulatory consultants and regulatory agencies to expand the use of TyraTech products in other countries.
- Ensure that the regulatory processes and systems established for TyraTech fully support the successful completion of the business objectives of the company and where needed, to develop and recommend changes and remedies to achieve compliance with the standards and goals of the Company.
- Develop working relationships for interaction with U.S. Federal and State regulatory personnel.
- Work effectively with partners, external agencies, resources and vendors to provide regulatory opinions on intermediates, formulations and new compounds.
- Provide regulatory guidance to Science and Productions teams for regulatory requirements as needed.
- Manage all regulatory strategies and activities, including corrective and preventative actions for continuous improvement.
- Work closely with other Commercial team members regarding registration requirements including, preparation of confidential statements of formula, chemistry packages, toxicology and other data required for registration.
Education, Knowledge, Skills and Abilities:
- Minimum B. S. Degree in applied science or business with a minimum of five-years of experience in managing industrial pest control and regulatory compliance activities. Relevant training and coursework in project management would be helpful.
- Proven direct experience in developing, implementing and managing regulatory programs and product registration in compliance with U.S. Federal and State requirements.
- Experience in regulatory and efficacy data generation, including data requirements for specific regulatory submissions.
- Demonstrated ability to attend to detail and perform multiple complex tasks.
- Communication ability with a broad range of scientific and commercial professionals including product development, biology, marketing and legal is needed.
- Direct experience in preparing submissions, notifications and reports to U.S. Federal and State EPA regulatory agencies.
- Experience in leading efforts in a start-up environment is desirable.
Environmental & Physical Demands:
- While performing the duties of this job, the employee is regularly required to speak clearly and hear.
- Ability to be mobile.
- May be subject to strenuous driving & travel conditions for long periods of time and lifting objects up to 20 pounds in weight.
- Specific vision abilities required by this job include close vision to computer monitors, distance vision, and peripheral vision.
- Maintain forty (40) hours per week performance level, plus additional hours, as job requires.
Contacts:
- Ability to maintain daily contact relationships with co-workers, supervisors/managers, and various organizational personnel.
- Ability to maintain periodic external contact relationships with Federal and State regulatory agency employees, consultants, vendors and other government personnel.
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