Manager, Regulatory Compliance


For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

Job Summary

We are seeking an experienced  Manager, Regulatory Compliance for our Safety Assestment site located in Mattawan, Michigan.

 

This position is responsible for managing the Quality Programs at a Charles River operation.  Assists Regulatory Affairs and Compliance Management in implementing the Charles River Compliance Program.  Works with the site management team to assure regulatory compliance and consistency with Charles River policies and procedures.

 

 

The following are the minimum requirements related to the Manager, Regulatory Compliance position:

 

  • Bachelor’s degree (B.A./B.S.) or equivalent
  • Minimum of five (5) years of experience in the pharmaceutical and/or biotechnology based industry. .
  • Experience in supervision quality assurance, quality control, and/or regulatory affairs.
  • Experience with assisting or managing GLP QA audits and inspections as well as interfacing with regulatory agencies.
  • Good working knowledge of pertinent regulations and site SOPs.
  • Demonstrates strong leadership ability, communication, and facilitation skills.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above

 

 

About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

 

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 13,000 employees within 80 facilities in 23 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges.  Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in 2017.

 

For more information, please visit www.criver.com.

 

Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet