Kelly® Science & Clinical is seeking a Manager, CMC Regulatory for a direct hire opportunity with one of our clients, a commercial-stage biotechnology company. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary: $130,000-160,000/year

Workplace: Onsite in Seattle, WA

Overview

The Manager, Regulatory Affairs (CMC) is responsible for providing regulatory support and guidance on CMC -related submissions to the FDA and other regulatory authorities worldwide. You will assist in the development and execution of CMC regulatory strategies, regulatory submissions (IND, BLA, NDA) in the area of Human Gene and Cell Therapies and/or other biologics.

Responsibilities

• Provides CMC regulatory support and guidance to project teams for clinical development and post approval changes; defines CMC regulatory submission strategies during development and post approval.
• Experienced with clinical trial (IND/IMPD/CTA) and marketing applications (BLA/NDA/MAA) filing requirements including content requirements, technical writing, and tracking timelines.
• Works with technical departments in R&D/Operations/Quality to develop high-quality submissions.
• Prepares and manages submissions to filings and supports review by regulatory authorities.
• Liaises with FDA and other regulatory authorities in written communication and participates in meetings on product development regulatory issues.
• Stays current with regulations and regulatory guidance documents.
• Responsibilities include preparing regulatory assessments of manufacturing changes, authoring department SOPs, etc.
• Prepares and/or reviews labeling, biological product deviation reporting, lot distribution reports, IND safety reports, clinical/investigator documentation, or other reports, as needed.
• May or may not manage direct reports.

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent
• 7 years of related experience in FDA FDA-regulated industry
• At least 3 years of experience in CMC regulatory affairs
• Experience with biologics required cellular therapy experience strongly preferred
• Experience with eCTD – electronic documents and submissions
• Knowledge of cGMP/ICH/FDA regulations

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.