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.

Job Description

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.
  1. 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.