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Regulatory Affairs Specialist

Req ID #:  45712
Location: 

Wilmington, MA, US, 01887

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 a Regulatory Affairs Specialist, for our Regulatory Affairs Department located in Wilmington, Massachusetts.

 

 

This position is responsible for supporting the Director, Associate Director or Manager of Regulatory Affairs with providing various business units with regulatory intelligence and proof of compliance requests. Assist Management with establishing and sustaining Regulatory Affairs as a comprehensive source for global regulatory information to increase regulatory compliance, manage regulatory risk and make informed regulatory decisions.

 

 

The following are the minimum requirements related to the Regulatory Affairs Specialist position:

 

  • Bachelor’s degree (B.A./B.S.) or equivalent in scientific or business related discipline. 
  • 1-2 years related experience in a Parmaceutical/ Botechnological/ Mdical Dece related industry in the area of regulatory compliance.
  • Must have excellent interpersonal and communication skills with the ability to influence.  Excellent English grammar is a must. Ability to multi-task and attention to detail. Ability to prioritize and re-evaluate priorities as situations change. Experience creating and maintaining databases. Working knowledge of computer software (MS Office, MS Project, Excel, and database experience). Technical writing skills and up to date knowledge of social media tools, best practices and how other organizations and companies are using new media.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

 

 

About Corporate Functions 

The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.

 

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 14,000 employees within 80 facilities in 20 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 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

 

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 ~85% of the drugs approved by the FDA in 2018.

 

Equal Employment Opportunity 

 

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet

 

 

 


Nearest Major Market: Boston

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