Make an impact. Build a career.
At Pace®, we’re committed to continuously moving science forward; to innovate and advance sustainable practices that improve the health and safety of our communities and lives. Ask any of us, and you’ll hear the same thing repeated again and again: we work here because what we do positively impacts the world.
If you’re curious, driven and inspired by the idea of doing important work with real-world impact, there’s no better place to build your career.
Find your place at Pace®
Join us as a CMC Regulatory Affairs Specialist, where you’ll put your love of science to work in the Scientific Insourcing Services department. You’ll receive all the training you need to successfully take on your new role and grow an exciting laboratory sciences career at Pace®.
The CMC Specialist will utilize their experience to assist in the preparation and review of documents for submission to the FDA, including formal FDA meeting requests and briefing packages, CMC components of investigational new drug (IND) applications, related progress reports, and amendments, and expedited approval programs. The CMC specialist will also perform regulatory strategy and gap analyses of clients’ materials to assess their needs as they move their drug through clinical development to marketing approval. The CMC specialist is expected to provide detailed feedback and advice into applications where clients have gaps or questions in their CMC methodology which may result in a clinical hold from the reviewing agency.
Note: Postion is Remote
Note: This is an evergreen posting for future positions with Pace. If you would like to be considered during the next round of hirings and have the qualifications, please apply.
What you’ll do
What you’ll bring
What we promise
About Pace®
PaceⓇ Science and Technology company makes the world a safer, healthier place. We partner with clients to provide the service, science, and laboratory data needed to make critical decisions that benefit us all. Through a nationwide laboratory network, PaceⓇ advances the science of businesses, industries, consulting firms, government agencies, and others. More at PACELABS.com.
PaceⓇ Analytical Services is a division of PaceⓇ Science and Technology, providing local testing and analytical services backed by a large, national laboratory network.
PaceⓇ Life Sciences is a division of PaceⓇ Science and Technology, providing full-service CDMO/CRO capabilities and professional services for in-house labs through a nationwide network of service centers, manufacturing sites and FDA-registered laboratories.
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