Health and Safety Compliance Officer

Req ID:  68032
Location: 

Saffron Walden, GB, CB10 1XL Harlow, GB, CM19 5TR

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 looking to recruit a Compliance Specialist within our UK Discovery unit. Reporting directly to the G&A Senior Director, you will provide strategic and operational input and expertise on regulatory compliance and related matters. You will be expected to interpret and deal with new legislation and regulations ensuring processes and procedures are in place to guarantee regulatory compliance for Early Discovery

 

Main responsibilities

1.    To provide expert compliance advice to senior management and all managers and staff within Discovery
a.    Advising on compliance policies with updates to senior management
b.    Ensure appropriate processes and procedures are in place to ensure compliance in:
•    Shipping
Shipping of various chemical and biological agents
Checking SAD documents
Understanding of assigning tariff codes. Understanding of duty exemptions and CPC codes. Restating incorrectly filed imports
•    Knowledge of VAT issues and IoR requirements for goods
•    Brexit
The impact on all aspects of UK EU trading 
•    New hazardous materials
Experience of ECHA notification process for hazardous materials.  Generating IUCLD dossiers asserting confidentiality over the identity of notified compounds 
•    Ozone depleters
Registration with ECHA for ozone depleter use (as precursor to UK system)
•    PoAO, CITES, Pathogens
Knowledge to work with BSOs etc and shippers and of the ethics requirements of ASPA and the 3Rs.
•    Human Tissue Act (England and Wales) 
Knowledge of what constitutes human relevant material.  Understanding of the difference between HTA licencing and NREC “approvals”.  Knowledge of HTA codes of practice, particularly code E Ability to support applications for NREC “Approval” and support the PI
•     Knowledge of GDPR 

2.    Leading investigations into compliance incidents
3.    Representing the company in interactions and partnering with statutory and regulatory bodies 
4.    Acting as a role model and mentor for all staff in compliance matters   
5.    Facilitating the smooth running of the business’s operations 
6.    Carrying out projects as delegated by management, delivering to time and budget
7.    Regular interaction with Charles River stakeholders across the business

 

Requirements

•    A degree or equivalent in a science subject 
•    5 years demonstrated advanced experience in compliance in the pharmaceutical/closely related sector 
•    Experience of operating in the compliance areas 
•    Knowledge of interactions with statutory regulators 
•    Demonstrated skills as a mentor / trainer 
•    Wide knowledge of regulatory and compliance issues that can affect the (Early) Discovery business and identifying/applying solutions 
•    Flexible and able to deal competently with issues that come in unexpectedly
•    Appropriate level of membership of professional / external bodies maintaining and updating regulatory knowledge and sharing of “best practice”
•    Approachable and able to deal with confidential matters with integrity
 

About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 350 patents and 80 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market.

 

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 17,000 employees within 90 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 2019, revenue increased to $2.62 billion.

 

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 2019.