Director, Regulatory and Compliance

For 75 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 anexperienced Director of Regulatory Services & Compliance to join our Insourcing Solutions team, located in Boston, MA, San Diego, CA, or San Francisco, CA. As the Director of Regulatory Services & Compliance , you will lead regulatory and compliance teams, client regulatory services, and the IACUC for NA Charles River Accelerator and Development Lab (CRADL) and NA Insourcing Solutions (IS) satellite sites including management of IACUC team, administrators, and consultants. Partner with IS operations to provide regulatory and compliance services for all IS service offerings. Act as the primary liaison with RMS and corporate regulatory and compliance groups, ensuring alignment across groups in compliance with corporate initiatives and driving standards of excellence. Lead the CRADL organization in AAALAC accreditation, OLAW assurance, and the strategic direction of the animal care and use program and all its components. Additional responsibilities include: Lead all communications with regulatory or accreditation agencies including AAALACi, OLAW, DEA, USDA, and Cambridge Commissioner. Lead preparation, coordination, paperwork and follow up, of internal and external site visits, audits, and inspections e.g., client audits, the IACUC, outside regulatory and accrediting bodies including AAALAC, DEA, OLAW, as well as internal corporate audits. Provide reports on all regulatory visits, audits, and any compliance issues to executive management, including but not limited to outcome, evolving status, response plan, impact to clients and to the business, lessons learned, and preventative measures taken in response. Develop vision and direction for all programs within job scope for regulatory and compliance services. Plan resources to align with business objectives, growth, and ensure service level is available at all sites. Assist with organizational goal setting and monitor high-level project deliverables. Assist in organizational business management, budgetary planning, and tracking, and proposes new business cases to executive management. Oversee the triaging, escalation, and resolution of compliance events identified to be lead by the regulatory and compliance group. Accountable for all regulatory consultants and/or IACUC community members that provide services within the NA CRADL and IS Satellite sites, including recruitment processes and requirements, reviewing, executing, and maintaining of all required paperwork such as service contracts, ensuring invoice and payment management. Job Qualifications The following are minimum requirements related to the Director of Regulatory Services & Compliance position. Veterinary degree (D.V.M./V.M.D.) or international equivalent is required. Ten (10) years of post-degree or post-residency experience in a laboratory animal setting with a rodent species focus including five (5) years of management experience. Industry/commercial experience with a customer service focus required. At least three (3) years of experience in managing laboratory animal program compliance. Licensure to practice veterinary medicine in at least one US state required. Diplomate ACLAM required. CPIA preferred. DEA licensure may be required upon hire. The pay range for this position is $210-250K USD annually . Please note that salaries vary within the range based on factors including experience, skills, education, certifications, and location. About Insourcing Solutions Charles River Insourcing Solutionsâ„ can streamline research by delivering operational and cost efficiencies through the strategic insourcing of GMP, GLP and non-GLP research services from discovery through safety assessment. Insourcing Solutionsâ„ provides you with the ability to maintain control of your facility and expertise while leveraging available space. 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 supported the development of 86% of the drugs approved by the FDA in 2021. Equal Employment Opportunity Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status. 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 . 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 223922

Created: 2024-10-19