Atrium Works
Atrium Works is hiring a contract Regulatory CMC Manager in the US to help steer Chemistry, Manufacturing, and Controls strategy for marketed cell and gene therapy products. If you thrive at the intersection of regulatory science and advanced therapeutics, this role puts your expertise at the center of getting life-changing medicines to patients.
About the Role
As the Regulatory CMC Manager at Atrium Works, you will drive the regulatory CMC strategy supporting commercialized cell and gene therapy products. Working closely with teams across the organization, you'll help shape, document, and submit the regulatory materials that keep these therapies compliant with applicable international standards. This is a US-based, full-time contract position.
Key Responsibilities
- Support the execution of regulatory CMC strategies for marketed cell and gene therapy products.
- Contribute to the planning, authoring, and submission of regulatory CMC documentation.
- Partner with cross-functional teams to provide regulatory guidance and ensure alignment with project goals.
- Help confirm that submissions and processes meet relevant international regulatory requirements.
Qualifications
- Experience in regulatory CMC, ideally within cell and gene therapy or related biologics.
- Familiarity with the preparation and submission of regulatory documentation for marketed products.
- Working knowledge of international regulatory requirements affecting advanced therapeutic products.
- Strong collaboration and communication skills for partnering with cross-functional teams.
- Ability to manage detailed regulatory deliverables within a contract engagement.
About Atrium Works
Atrium Works supports the development and commercialization of innovative cell and gene therapies. Our teams bring regulatory and technical specialists together to advance complex therapeutic products and keep them compliant across global markets.
How to Apply
Ready to make an impact as a Regulatory CMC Manager with Atrium Works in the US? View the full listing and apply here.
To apply for this job please visit www.adzuna.com.
Working in US
The United States of America (USA), also known as the United States (U.S.) or America, is a country primarily located in North America. It is a federal republic consisting of 50 states and a federal capital district, Washington, D.C. The 48 contiguous states border Canada to the north and Mexico to the south, with the semi-exclave of Alaska in the northwest and the archipelago of Hawaii in the Pacific Ocean. The United States also asserts sovereignty over five major island territories and various uninhabited islands in Oceania and the Caribbean. It is a megadiverse country, with the world's th
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