Regulatory Affairs Specialist

Los Alamos
Posted 3 weeks ago

Location: Los Alamos, NM

Compensation: $65K – $85K+

About this opportunity: 

Pebble Labs is a cutting-edge biotechnology company dedicated to using science to improve human condition, by developing novel strategies to address real life problems in a sustainable and environmentally conscious manner. We are rapidly growing and are looking for enthusiastic and driven contributors to join a multicultural and diverse scientific team.

  • Develop registration dossiers for Pebble Labs products
  • Accountable for timely registrations
  • Serve as functional regulatory support and compliance expert.
  • 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

  • At least a Master’s degree with direct science and/or regulatory experience.
  • 2+ years of experience in a scientific role.
  • GMP/ CGMP experience preferred
  • 1+ years of experience in a regulatory, product development, or technical role.
  • Experience working in the medical, veterinary, agriculture, or pesticide industry.
  • Knowledge of regulatory policies, guidelines from global regulatory agencies including FDA, USDA, and EPA.
  • Proficient IT capabilities including document-based management systems experience.
  • Well-organized, good interpersonal and strong communication skills, written and verbal.
  • 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.

 

 

 

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