North American Regulatory Lead
At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families.
Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career.
As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.
Job Summary
Responsible for supporting regulatory compliance for all North American sites, including but not limited to United States Department of Agriculture (USDA), Office of Laboratory Animal Welfare (OLAW), Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), Canadian Council on Animal Care (CCAC) compliance. Responsible for harmonization of Institutional Animal Care and Use Committee (IACUC) function across North America. Responsible for coordination and archiving reporting to regulatory agencies and maintaining documentation for regulatory accreditation and licensure in a centrally accessible archive. Point of contact for regulatory expertise supporting decision making by Institutional Officer (IO) and IO delegates.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Harmonize and assure escalation of semi-annual inspection reports from all North American sites
- Develop and deliver harmonized training for IACUC administrators, chairs and members
- Develop and deliver annual IACUC member training
- Develop and maintain harmonized IACUC meeting minutes and protocol submission format
- Support IACUC administrators to maintain IACUC and animal care program records to allow for timely retrieval during regulatory, accreditation, and sponsor audits.
- Review IACUC policies and current practices and propose changes as appropriate.
- Review and coordinate appropriate webinars or other continuing education opportunities for IACUC members, maintain records of such training.
- Maintain information sharing and alignment in regulatory compliance between North American sites
- Review, harmonize and assure completion and submission of annual reports to AAALAC, USDA, and OLAW in cooperation with the IO and/or IO delegates.
- Review all sites tri-annual AAALAC Program Description and application, harmonize language between all North American sites in sections where possible in cooperation with the IO and/or IO delegates.
- Review and harmonize PHS Assurances for all sites (globally) and assure timely submission to OLAW in cooperation with the IO and/or IO delegates.
- Attend closure meetings for USDA and North American AAALAC inspections/site visits; collate feedback for cross-site sharing, escalate to the IO and/or IO delegates as required for action/follow-up.
- Oversee provision of training to study directors, study coordinators, and others involved in study work utilizing US federal grant funding.
- Lead the Government Grants Team or other North American regulatory teams as assigned.
- Revise Vertebrate Animal Section (VAS) documents for clients, complete congruency checks between Statement of Work (SOW), VAS, and approved protocol, assist in completion and submission of Interinstitutional Assurances (IIAs).
- Assist in completion of Animal Care and Use Review Office (ACURO) forms and submission to the Department of Defense (DOD).
- Assist in the development, maintenance, and communication of departmental systems.
- Serve as a resource to scientific staff, operations staff, and IACUC members on regulatory inquiries/requirements.
- Perform all other related duties as assigned.
Job Qualifications
- Education: Bachelor’s degree (BA/BS) or equivalent preferred.
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Experience: 5-10 years’ experience. Experience working in a laboratory animal environment preferred.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: CPIA certification.
- Other: Knowledge of USDA regulations, AWA, PHS policy, AAALAC regulations, and “the Guide” required. Excellent organizational skills, especially with time management and record keeping. Must be able to work independently and manage matrix staff. Excellent written and verbal communication skills.
- Computer skills (e.g., Microsoft Office Suite), commensurate with essential functions, including the ability to learn a validated system.
Compensation Data
The pay range for this position is $93,000 - $103,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
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 20,000 employees within 110 facilities in over 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.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to [email protected]. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
