We are seeking Regulatory Affairs CMC Writers! Learn more about the general tasks related to this opportunity below, as well as required skills. We are looking for qualified Regulatory Affairs CMC professionals to support the development and commercialization of radiopharmaceutical and biopharmaceutical products. Author and develop CMC-specific regulatory dossiers, including eCTD Module 3 – Sections 3.2.S and 3.2.P.Prepare high-quality technical content covering Drug Substance and Drug Product requirements. Apply strong knowledge of Quality/CMC regulatory requirements to ensure submission-ready documentation. Collaborate with CMC, Quality, Analytical, Manufacturing, and Regulatory teams to develop accurate technical content. Ensure consistency, accuracy, completeness, and traceability across regulatory Module 3 documentation. Experience with Veeva for regulatory authoring and document management is highly preferred. Support regulatory dossier preparation, review, updates, and revisions throughout product development and commercialization. Demonstrate strong scientific knowledge and the ability to translate complex technical information into clear regulatory language. Candidates should have strong experience with eCTD Module 3 authoring and CMC regulatory submissions. xevrcyc Interested candidates are encouraged to reach out with their CV or connect for further details.
