Strategy Visa Sponsorship Jobs in Massachusetts

INTRODUCTION

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 Overview

This strategic role is responsible for the regulatory strategy and compliance position of Charles River’s Biologics Testing Solutions (BTS) business unit, with specific accountability for how BTS methods and data are justified, defended, and maintained in client regulatory submissions.

The role sits at the interface between BTS operations and client regulatory affairs. The individual in this role advises clients on testing strategy, method selection, comparability, and the regulatory justification required at each stage of a program; supports client filings and responses to health authority questions arising from BTS-generated data; and ensures that BTS Master Files, method validation packages, and quality system processes meet current regulatory expectations across all applicable jurisdictions.

The role is also responsible for regulatory intelligence: monitoring evolving expectations for biologics safety testing, including alternative and non-animal methods, and translating those expectations into BTS internal standards, client guidance, and external positioning. Success in the role requires regulatory depth combined with the scientific credibility and client-facing capability necessary to guide sponsors through method transitions and submission-level decisions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Client Regulatory Strategy and Support

• Serve as the primary regulatory point of contact for BTS clients on testing strategy, method selection, and the justification of BTS-generated data within regulatory submissions.
• Advise clients on regulatory requirements applicable to adventitious agent testing, viral safety, cell bank characterization, and lot release testing across development phases and across FDA, EMA, and other applicable jurisdictions.
• Support client preparation of CMC content, method justification, and comparability arguments where BTS data is relied upon; review client-facing regulatory documentation for technical and regulatory accuracy.
• Prepare and coordinate responses to health authority questions and information requests arising from BTS methods or data, working with client regulatory teams and BTS technical staff.
• Guide clients through method transitions, including the replacement of in vivo and traditional compendial methods with alternative approaches, ensuring comparability, validation, and phase-appropriate justification expectations are addressed.
• Participate in client meetings, technical assessments, and pre-submission discussions; represent BTS regulatory positions to client scientific, quality, and regulatory leadership.
• Develop and maintain client-facing regulatory guidance materials, decision tools, and technical justification templates that allow clients to act on BTS regulatory positions.

Regulatory Intelligence and Positioning

• Monitor new and changing regulations, guidance, and compendial requirements affecting biologics safety testing, including ICH, FDA, EMA, Ph. Eur., USP, and JP, and assess the impact on BTS services and client programs.
• Communicate regulatory changes and resulting gaps through site and global Quality Management Reviews; ensure mitigation actions are defined, owned, and tracked to closure.
• Develop and maintain the BTS regulatory position on alternative methods and the reduction of animal testing; ensure internal standards and client-facing materials reflect current agency expectations.
• Author regulatory strategy documents, position papers, and technical justifications supporting BTS methods and service offerings.
• Represent BTS at regulatory forums, industry working groups, and scientific conferences; contribute to publications and external engagement as directed.
• Work with Quality and Regulatory leaders across all Charles River business units to identify and implement best practices in the regulatory space.

Compliance and Quality System

• Monitor the adequacy of site Master Files and Drug Master Files across the BTS network, including periodic review requirements and the timeliness and accuracy of updates.
• Serve as the coordination point for regulatory agency interactions relating to BTS methods and Master Files, in conjunction with site Heads of Quality and Qualified Persons.
• Facilitate the development of harmonized regulatory compliance standards and Quality Agreements across the BTS site network; review applicable policies and procedures and advise management on regulatory risk.
• Communicate all identified regulatory and compliance risks to site and global leadership.
• Ensure site quality and compliance staff receive appropriate regulatory training and mentoring to enable the execution of their regulatory responsibilities; consult with the Global Quality team on the design of regulatory and GMP training content.
• Perform all other related duties as assigned.

Qualifications

• Education: Bachelor’s degree (B.A./B.S.) in a scientific discipline required. Advanced degree (M.S., Ph.D., Pharm.D., D.V.M.) in a biological or pharmaceutical science preferred.

• Experience: Minimum of eight years’ regulatory affairs and/or GMP quality experience in the pharmaceutical or biotechnology industry, including direct experience supporting biologics regulatory submissions.

• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

• Minimum of five years’ experience interacting directly with FDA and EU health authorities.

• Five to seven years’ experience with pharmaceutical and/or biotechnology audits and inspections.
• Demonstrated experience authoring or supporting CMC content within IND/IMPD, BLA/MAA, or equivalent submissions.
• Working knowledge of biologics safety testing requirements, including ICH Q5A(R2), viral clearance, adventitious agent testing, and cell bank characterization. Familiarity with sequencing-based methods and Ph. Eur. 2.6.41 preferred.
• Demonstrated ability to develop and defend regulatory strategy in writing, including the construction of scientific and regulatory justification for method selection and method change.
• Experience in a CRO, CDMO, or other client-facing regulatory role strongly preferred, with demonstrated credibility in front of client regulatory and technical leadership.
• Ability to deliver complex technical and regulatory information in a digestible format to audiences at varying levels, including senior client stakeholders.
• Detail-oriented, with the ability to manage complex problems, maintain a high level of confidentiality, require minimal direction, and work within a team environment.
• Ability to manage, prioritize, and multi-task various responsibilities.
• Ability to travel domestically and internationally to support sites, clients, and external engagements as needs arise, approximately 15% of time.

Compensation Data

The pay rate for this role is $130,000 - $150,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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 crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.