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Manager, Regulatory Compliance - United States  

Company managed [?] Still accepting applications

Posted on : 13 June 2017

Project Description

Company Statement
  • For nearly 70 years, our company 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.



Responsibilities
  • We are seeking an experienced Regulatory Compliance Manager, for our Safety Assessment site.
  • This position is responsible for managing the Quality Programs at a company operation.  
  • Assists Regulatory Affairs and Compliance management in implementing the company Compliance Program.  
  • Works with the site management team to assure regulatory compliance and consistency with company policies and procedures.



About Safety Assessment Business
Our company 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.



Qualifications
The following are minimum requirements related to the Regulatory Compliance Manager 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 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 Us: 
  • For nearly 70 years, our 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. 
  • Our company 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.  
  • Our company 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 11,000 employees within 70 facilities in 18 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. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.  
  • 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 ~70% of the drugs approved by the FDA in 2016. 



Equal Employment Opportunity
Our company  is an Equal Opportunity Employer M/F/Disabled/Vet