Regulatory Affairs Manager
Job Title: Regulatory Affairs Manager
Department: Manufacturing and Regulatory Affairs
Reports to: Vice President of Manufacturing and Regulatory Affairs
FLSA Status: Exempt
SenesTech, Inc. is a growing biotech company built upon a mammalian pest-management technology using fertility control. Our first rodent-specific product, ContraPest®, was registered with the EPA in August of 2016 for indoor, restricted, non-food use. Our R&D teams are continuing to work on label improvements to outdoor and non-restricted use in addition to additional products that will require future filings with EPA, and potentially USDA, FDA, etc.
Reporting directly to the Vice President of Manufacturing and Regulatory Affairs, the Regulatory Affairs Manager is responsible for management of all regulatory functions associated with SenesTech products. The core duty of this position is to manage label improvements for existing registrations, prepare submission documents for new EPA product registration submissions, and provide risk-management advice for product management in compliance with the requirements of regulatory agency(s). Additionally, the position is responsible for ensuring and improving efficiency of regulatory filings and management of any required follow-on materials. Current registrations are US-only, however, ability to provide global regulatory guidance is preferred. The ideal candidate will be flexible and creative in their problem-solving skills and will provide advice, support, and guidance to the organization in regards to regulatory issues. Specific areas of responsibility include registration process compliance with EPA and state-specific regulations. All activities are performed in the spirit of teamwork and cooperation practiced at SenesTech.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Responsible for implementation of domestic regulatory strategies and guidance of international opportunities and coordination of regulatory affairs.
- Maintain records and submit filings in connection with various US state and federal requirements.
- Understand and communicate all product-relevant federal and state laws/regulations. Assist the company in addressing regulatory changes.
- Compile and maintain appropriate technical documents for regulatory reporting and new submissions; prepare and submit documentation to regulatory agencies.
- Provide guidance to research personnel to support regulatory submissions.
- Work closely with Sales and Marketing departments to provide guidance to ensure written material is compliant with US registrations.
- Manage preparation, coordination, and compiling of applications to domestic regulatory agencies.
- Provide guidance for international regulatory efforts.
- Communicate and correspond with regulatory agencies.
- Communicate with company legal and regulatory consultants as to regulatory rules, rule changes, and provide guidance for communication through corporate policies and procedures.
- Responsible for administrative tasks such as: maintaining all required records, routing correspondence (telephone and email), and scheduling appointments involving product regulatory issues.
- Responsible for implementing training guidelines and training all members of the team on important regulatory issues or changes.
- Provide guidance for implementation plans for the organization in regards to basic product regulatory compliance.
- Respond to routine inquiries from marketing, sales, and operations, and regulatory agencies.
- Review and approve any marketing / sales collateral pertaining to registered products for compliance with EPA and FTC guidelines.
- Coordinate customer-complaint reviews to ensure any required regulatory reports/paperwork is filed. .
- Ensure regulatory compliance issues are communicated to all relevant departments and maintenance of regulatory documentation databases or systems.
- Provides technical review of data and reports that will be incorporated into regulatory submissions to assure completeness of the package.
- Special projects as assigned.
Required Knowledge, Skills and Abilities
- Must be able to apply principles of critical-thinking to a variety of practical and emergent situations, and accurately follow standardized procedures while providing guidance where deviations may be appropriate.
- Must excel at reading comprehension and critical thought as many of the primary responsibilities of the position include review of analytical research.
- Responsible for active engagement with assigned tasks; strong organizational skills, with great attention to details as this position is required to relay information clearly and concisely to multiple parties (both internal and external to company).
- Ability to demonstrate excellent verbal and written communication skills required to write reports and present materials/knowledge to upper-management. (Technical writing samples and oral presentation may be required of candidates.)
- Ability to self-motivate to stay apprised of current information on new regulations and laws as they become available.
- Ability to effectively communicate in a confidential-manner when speaking with colleagues and Regulatory Agencies about sensitive and confidential matters.
- Ability to effectively work in an organization where results are achieved by working cooperatively with a diverse group of professionals.
Education and Experience
- Bachelor degree in science, project management or a related field and five years professional experience in either the EPA or FDA regulatory field; OR Master degree in management, business, science, or related field and three years professional experience in either the EPA or FDA regulatory field; or combination thereof required.
- Knowledge of, or direct experience in, application submission to EPA or other U.S. federal regulatory entity a plus.
Physical Demands and Travel Requirements
- This position allows for telecommuting should candidate not be located in Flagstaff, AZ. Position requires, regular communication via phone/email/or wed conferencing with direct supervisor to ensure tasks are being managed and accomplished is a timely manner.
- Most work is performed while sitting or standing at a desk with a computer.
- Ability to lift 35 pounds required.
- Ability to use standard office equipment including computer, telecommunications equipment, desk or cell phone, copier, and fax machines.
- Minimal travel to meet with regulatory liaisons or attend conferences may be required.
- Regular (bimonthly or quarterly) travel to meet face-to-face with direct supervisor and company officers is required.
$75,000-$100,000 DOE per year based on 1.0 FTE; this is a .5 FTE (20 hours per week) position and salary is based on annual compensation. This is a non-benefit eligible position. SenesTech is a publicly-traded company and stock options may also be available as supplemental, performance-based compensation.
SenesTech is an equal opportunity employer with a commitment to diversity. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation or protected veteran status.
SenesTech conducts background checks on all final candidates.
To apply for this job email your details to Careers@SenesTech.com