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Manager, Regulatory Compliance

Req ID #:  40473
Location: 

Shrewsbury, MA, US, 01545

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 Biologics located in Shrewsbury, MA.

 

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 GMP 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 Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

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

 


Nearest Major Market: Worcester

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