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Parexel International

Remote Senior Regulatory Affairs Associate - CMC (Vaccines)

town of italy, NY

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Job description

Parexel International seeks a Senior Regulatory Affairs Associate to join our global post-approval team, focusing on CMC for biological and vaccines products. Office or home-based in Europe; remote work options available.

You will develop submission strategies, assess change controls, and coordinate submissions across manufacturing, QA, QA, and local affiliates. Strong English, CMC knowledge, and regulatory writing experience are essential for success.

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