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Regulatory Affairs Senior Specialist III

Phoenix, ArizonaRemote
About the Job
Regulatory Affairs Senior Specialist III (Hybrid/Remote)

SUMMARY
Seeking a subject matter expert responsible for creating and executing regulatory strategies; coordinating regulatory planning aimed at achieving and maintaining approvals for clearances of new, modified, and existing products involving all pre-market and post-market activities. A creative, solution-based, and curious mindset with the desire for managerial growth is required. 
 
Primary responsibilities include evaluation, coordination, preparation, and implementation of pre- and post-market regulatory activities and design change evaluations. Additionally, this position recommends a regulatory strategy for new product development activities and applicable submissions or registrations. This role is responsible for managing regulatory initiatives and working with SenesTech’s product development team as well as third parties such as suppliers and consultants, as appropriate to build consensus while championing regulatory initiatives for projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES
  • Under the direction of the Technical Product Director, provides strategic regulatory leadership and guidance to the project teams.
  • Defines regulatory expectations for teams, develops positions for responses to regulatory agencies, defines a strategy for negotiations and formal document submission, and provides strategic input in the development of the plan.
  • Identifies and communicates potential risks and creative solutions to mitigate those potential risks associated with regulatory strategies to stakeholders.
  • Interacts with regulatory agencies and ensures conversations and communications are focused, amicable, and documented.
  • Oversees and manages the submission of product registration of new products, progress reports, and periodic adverse experience reports. Develops innovative strategies, drafts responses, and/or reviews responses and documents intended for submission to EPA or other authorities to assure compliance with regulatory standards.
  • Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to US EPA, state, and international regulatory agencies.
  • Accountable for establishing, maintaining, adjusting, and communicating regulatory submission deadlines to ensure that all product-launch-related functional area activities can be planned accordingly.
  • Prepares regulatory submissions required by the US EPA, and state and international government agencies, including requisite pre-submissions and post-market approval reports. Ensures regulatory submissions are prepared and processed in a proactive expeditious and timely manner.
  • Remain current on standards, guidance, and regulations affecting SenesTech; assess and communicate potential impact.
  • Trains, and coaches’ staff; evaluates employee performance on an ongoing basis for direct (if any) or indirect reports and completes annual performance reviews as appropriate.
  • Other duties as assigned.  

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
  • Knowledge of, or direct experience in, application submission to US EPA and state agencies.
  • Ability to manage multiple projects, meet deadlines, and prioritize/organize complex information.
  • Curious and solution-based mindset, who is willing to approach any situation with a can-do attitude. 
  •  Ability to manage employees and employee projects.
  • Excellent interpersonal, communication, team building, and analytical skills.
  • Demonstrated ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. 
  • Critical proofreading skills for review of labeling, marketing materials, social media, and other materials to assure accuracy and compliance with applicable regulations.

EDUCATION AND EXPERIENCE
  • Bachelor’s degree in a physical or life science or related field and/or five years of professional experience in the regulatory field preferably with EPA experience with rodenticides and/or pesticides.  Candidates with a background in quality or manufacturing of regulated products may also be considered.
  • Experience interpreting subjective and complex aspects of specific regulations and a thorough understanding of multiple sets of associated regulations.
  • Demonstrated success preparing, filing, and completing regulatory submissions.
  • Experience supporting product development and product support projects, including complex projects involving ambiguity and rapid change.
  •  Demonstrated success understanding advanced technical/scientific principles that relate to multiple, diverse, and/or complex product lines or manufacturing processes.
  • Experience analyzing complex issues and formulating cogent approaches to address them. 
  • Experience working in a fast-paced, ever-changing, start-up environment.

PHYSICAL DEMANDS AND TRAVEL REQUIREMENTS
  • This position allows for telecommuting should the candidate not be located in Phoenix, AZ. The position requires, regular communication via phone/email/or web conferencing with the direct supervisor to ensure tasks are being managed and accomplished in a timely manner. 
  • Minimal travel to meet with the team, and regulatory liaisons, or attend conferences may be required.
  • Most work is performed while sitting or standing at a desk with a computer.
  • Ability to use standard office equipment including computer, telecommunications equipment, desk or cell phone, copier, and fax machines.
  • Ability to lift 35 pounds required. 

PRE-EMPLOYMENT REQUIREMENTS
  • Non-disclosure agreements are required of all candidates during the interview process to protect company confidential and proprietary information.
  • Position-specific aptitude assessments will be conducted on all second-round candidates.
  • Various background, driving, employment, and education verifications, and clean drug screens are required and will be run for all final-round candidates.
  • Occupational health assessments and position-specific vaccinations may be required for specific positions. 

COMPENSATION & BENEFITS
SenesTech offers competitive compensation based on experience and the current market. This is a non-exempt, full-time, benefit-eligible position requiring 40 hours of work per week; yet may require overtime in extenuating circumstances approved by the leadership team. SenesTech is a publicly traded company and stock options may also be available as supplemental, performance-based compensation.
For our benefits package and interview process, please see our careers site at https://senestech.betterteam.com/
 
TOTAL REWARDS PACKAGE
  • Flexible schedules.
  • A robust PTO package includes 2-4 weeks ‘accrued vacation, ~13 paid holidays, 1 week (40 hours) of paid sick leave, and up to 2 personal days. 
  • Companywide events with catering
  • Medical, Dental, and Vision Insurance for eligible employees
  • Long-term and short-term disability
  • Voluntary benefit packages offered include pet insurance, accident & critical illness coverage, and legal retainer insurance. 
  • Employee contribution 401K program
  • Company advancement opportunities
  • Equity compensation and spot bonus programs may be available as supplemental, performance-based compensation.
  • Position-based company-provided software and hardware; position specific.
 
SenesTech is an at-will employer meaning your employment is for an indefinite period and it is subject to termination by you or your employer, with or without cause, with or without notice, and at any time. 
SenesTech is an equal-opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws and make all hiring decision based solely on qualifications, merit, and business needs at the time.  
SenesTech requires a series of screenings, clearances, and verifications on all final candidates, and any offers are contingent on the results of those clearances.
OUR STORY

SenesTech, Inc. is a platform life sciences company specializing in reproductive physiology. We are the makers of ContraPest® - Birth Control for Rats™. A liquid contraceptive bait targeting both male and female Norway and roof rats, ContraPest will profoundly change the world via animal pest population management. Our revolutionary technology is helping get control of rat populations in all different settings: commercial, agricultural, zoos and sanctuaries, government owned properties and is used by pest management professionals across the United States. To learn more, visit our websites: www.senestech.com and www.contrapeststore.com.