CMC Biopharma Regulatory Consultant — Ecolab Life Sciences

Ecolab • King of Prussia, PA

22d

About The Position

Ecolab Life Sciences, the world leader in resin‑based separation, purification, and extraction technologies, is seeking a Global Biopharma Regulatory Consultant to support our rapidly growing Bioprocessing division. Ecolab’s high‑performance Purolite™ Resins are critical to the safe and effective manufacture of pharmaceutical and biopharmaceutical products. Our chromatography solutions help customers around the globe produce medicines and therapies with the highest levels of purity, quality, and safety. This is an exciting opportunity to contribute to a mission that truly helps make the world cleaner, safer, and healthier. What's in it for you: The Global Biopharma Regulatory Consultant will play a key role in supporting global biopharma customers with regulatory filings and interactions with governmental authorities. Working across multiple internal teams, geographic regions, and time zones, this role ensures customers receive accurate, timely, and compliant regulatory support. You will collaborate closely with colleagues across Regulatory Affairs, Quality, R&D, Product Management, and Commercial teams to help biomanufacturers meet international regulatory standards. You will also engage with external stakeholders—including regulatory bodies—to support customer submissions and ensure global compliance. About Ecolab Life Sciences Ecolab Life Sciences is a global leader dedicated to helping biopharmaceutical manufacturers achieve excellence in safety, compliance, and operational performance. We deliver end‑to-end solutions backed by deep scientific expertise and a strong commitment to patient safety. Our work is grounded in a comprehensive understanding of global regulatory expectations and the rapidly evolving landscape of pharmaceutical production. By aligning innovative technologies with cGMP and international regulatory frameworks, we empower customers to operate confidently in highly regulated environments. What You Will Do Global CMC Leadership: Serve as a trusted strategic partner for Ecolab’s biopharma customers, providing expert guidance on filing strategies for chromatography and other downstream purification unit operations. Accelerate regulatory timelines and secure regulatory success for our customers through proactive, science-driven solutions. Regulatory Excellence as a Growth Driver: Collaborate seamlessly with Sales, R&D, Quality, and Bioprocess Development teams—both internally and externally—to execute CMC regulatory strategies, reduce time-to-market, strengthen compliance, and enhance customer competitiveness. Proactive Regulatory Foresight: Anticipate and influence evolving global regulations to design forward-looking CMC strategies. Support internal product development and bioprocess development initiatives to align with upcoming regulatory changes. Strategic Alignment for Business Impact: Integrate regulatory planning with commercial objectives to deliver measurable customer value. Accelerate adoption of Ecolab’s downstream processing solutions, optimize regulatory pathways for customers, and fuel sustainable business growth.

Requirements

• Bachelor's degree and 10 years of experience
• Extensive experience in CMC regulatory filing within biopharma with focus on downstream purification steps.
• Proven ability to lead global regulatory strategies and influence industry standards.
• Must be able to travel of at least 50%

Nice To Haves

• More than 5+ years of demonstrated experience in authoring CMC content for IND/BLA or PACMP with FDA and European agencies
• Advanced degree in Life Sciences related fields
• Strong collaboration skills with commercial and technical teams.
• Excellent communication and advocacy capabilities.

Responsibilities

• Serve as a trusted strategic partner for Ecolab’s biopharma customers, providing expert guidance on filing strategies for chromatography and other downstream purification unit operations.
• Accelerate regulatory timelines and secure regulatory success for our customers through proactive, science-driven solutions.
• Collaborate seamlessly with Sales, R&D, Quality, and Bioprocess Development teams—both internally and externally—to execute CMC regulatory strategies, reduce time-to-market, strengthen compliance, and enhance customer competitiveness.
• Anticipate and influence evolving global regulations to design forward-looking CMC strategies.
• Support internal product development and bioprocess development initiatives to align with upcoming regulatory changes.
• Integrate regulatory planning with commercial objectives to deliver measurable customer value.
• Accelerate adoption of Ecolab’s downstream processing solutions, optimize regulatory pathways for customers, and fuel sustainable business growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level