Associate Director of Regulatory Affairs

Posted 1 month ago

Location: Los Alamos, NM

Ability to work remotely during COVID-19 

Compensation: $90K – $125K+ 

 

About this opportunity: 

Pebble Labs is a cutting-edge biotechnology company dedicated to creating safe, sustainable solutions for global food security issues. Our mission is to develop breakthrough disruptive technologies that address the greatest agriculture, aquaculture, and environmental challenges facing the globe. We are rapidly growing and are looking for enthusiastic and driven contributors to join a multicultural and diverse scientific team.

In this role, you will have the opportunity to join an early stage biotechnology research and commercialization company. You’ll join the regulatory team working with the VP of Regulatory on all regulatory initiatives for our agricultural and aquaculture products. This is a key role that will be part of the strategic direction as well as driving the execution of the company’s regulatory initiatives. 

Pebble Labs is located in the scientific hub of Los Alamos, New Mexico and draws upon the synergy of one of the top laboratories in the United States. Neighboring Santa Fé and Taos communities with its diverse cultural, artistic and music scene, together with outdoors activities including skiing, hiking and fishing in the southern tip of the Rocky Mountains, offers a unique living and family friendly environment.

Learn more about Pebble Labs at pebblelabs.com

  • Develop registration dossiers for Pebble Labs products
  • Accountable for timely registrations
  • Serve as functional regulatory support and compliance expert for
    • Agricultural Products
    • Animal Probiotics Products
    • Human Supplement & Ingredient Products
  • Develop up-to-date registration requirements, procedures, and registration timelines
  • Ensure regulatory compliance for all regulated trials 
  • Develop and engender trusted relationships with internal/external stakeholders

 

What we’re looking for

  • Bachelors with at least 6 years experience
    • Preferably a Masters degree with direct science and/or regulatory experience
  • 2+ years of experience in a scientific role
  • RAC Certification preferred 
  • GMP/ CGMP experience preferred
  • 3+ years of experience in a regulatory, product development role
  • Experience working in the medical, veterinary, or agriculture industry
  • Extensive knowledge of regulatory policies, guidelines from global regulatory agencies including FDA, USDA, and EPA.
  • Proven experience of leading forward innovative regulatory strategies including: 
    • Providing competitive advantage through strategy execution
    • Experience working with novel regulatory pathways 
  • Comfortable with ambiguity and complexity
  • Deliver results in first‐time situations through personal drive and collaborative interactions
  • Excellent interpersonal skills – be an effective team player who can engender credibility and confidence within and outside the organization 
  • Proficient IT capabilities including document-based management systems experience.
  • Strong problem-solving skills and the ability to work and understand complex projects.
  • Works well with supervision with the goal towards the ability to work independently.
  • Detail oriented to ensure timely and successful product registration outcomes.
  • Science and data driven
  • Results Oriented Mindset – have a results-oriented work ethic with a positive, can-do attitude 

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