Regulatory Affairs Manager (Madison)

Job Title: Global Regulatory CMC Manager

Location: 50% Onsite – Giralda Farms, NJ

Duration: 6 Months (Contract)

Pay Range: $90–$100/hr (W2)

Work Hours: Monday–Friday, 8:00 AM–5:00 PM

Job Description

TSR Consulting is currently seeking a Global Regulatory CMC Manager for a 6-month contract opportunity with a leading pharmaceutical client at Giralda Farms, NJ.

The Global Regulatory Chemistry, Manufacturing, and Controls (CMC) team provides regulatory expertise throughout the product lifecycle, supporting development, global submissions, manufacturing changes, and post-approval activities. The selected candidate will collaborate with Global Regulatory Sciences, Global Product Development and Supply, and Cell Therapy Development Operations to ensure regulatory compliance and successful submissions.

Responsibilities

• Prepare, review, and maintain CTD Module 3 (Quality/CMC) documentation for IND, NDA, BLA, MAA, and post-approval submissions.
• Support regulatory CMC activities for pipeline products from development through commercialization and lifecycle management.
• Provide regulatory guidance to development, manufacturing, quality, and technical operations teams.
• Assess manufacturing change controls and determine their global regulatory impact.
• Interpret global regulations and guidance and communicate requirements to cross-functional stakeholders.
• Support health authority responses, regulatory commitments, and CMC-related discussions.
• Identify regulatory risks, recommend mitigation strategies, and communicate potential impacts on submissions and product supply.
• Manage submission timelines, documentation, and regulatory tracking using electronic systems.
• Contribute to CMC policies, procedures, and continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in a relevant scientific or technical discipline.
• 6+ years of Regulatory CMC experience in the pharmaceutical, biotechnology, or life sciences industry.
• Direct experience authoring or significantly contributing to CTD Module 3 content.
• Experience supporting IND, NDA, BLA, and/or MAA submissions.
• Hands-on regulatory experience supporting Cell Therapy and/or Gene Therapy products.
• Knowledge of CMC regulatory requirements for advanced therapies, biologics, and small molecules.
• Experience with eCTD submissions, publishing, and lifecycle management.
• Familiarity with regulatory publishing tools such as DocuBridge or similar platforms.
• Strong technical writing, communication, analytical, and problem-solving skills.
• Ability to collaborate across cross-functional teams and manage multiple priorities independently.

Preferred Qualifications

• Experience assessing manufacturing change controls and global change management.
• Direct experience supporting health authority interactions and regulatory responses.
• Familiarity with electronic regulatory information and quality management systems.

Additional Requirements

• Must be available to work 50% onsite at Giralda Farms, NJ .
• Work schedule: Monday–Friday, 8:00 AM–5:00 PM.
• Ability to travel up to 5%.

About TSR

TSR Consulting is a trusted staffing and workforce solutions partner with more than 50 years of experience delivering highly qualified talent to support clients’ critical business and technology initiatives. TSR helps organizations scale teams quickly while maintaining quality and reliability.

In June 2024, TSR was acquired by Justin Christian, founder and CEO of BCforward, a global provider of professional services and workforce solutions. This partnership expands TSR’s capabilities, global delivery resources, and opportunities for clients and consultants.