Regulatory CMC Writers

📢 We are seeking Regulatory Affairs CMC Writers! 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.📩 Interested candidates are encouraged to reach out with their CV or connect for further details.