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CMC Regulatory Affairs Manager
Seattle, WA, US
Scientific
Bachelors Degree
Full Time, Direct Hire
$130,000-160,000/year
Experienced (Non-Manager)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Seattle, WA, US
$130,000-160,000/year
Experienced (Non-Manager)
Full Time, Direct Hire
Biotechnology/Pharmaceuticals
On-site
Scientific
Bachelors Degree
First Shift (Day)
Job details
Kelly® Science & Clinical is seeking a Manager, CMC Regulatory Affairs for a direct hire opportunity with one of our clients, a commercial-stage biotechnology company at their Seattle, WA location. 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 requirement, 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 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.
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Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.