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.
UTOPIA BAGELS- LIC 26-11 Jackson Avenue Long Island, NY 11101 Utopia Bagels was founded in 1981 as a neighborhood establishment in Queens, New York. During its humble beginnings the store was a local favorite serving hot bagels, pastries, and coffee to a loyal customer...
...jitter bugs, and drills.Install thread inserts, keenserts, and a range of fasteners.Run and troubleshoot equipment such as electro etchers, hydro test pumps, and vacuum pumps.Handle materials with fork trucks and overhead cranes.Enter accurate data into the IDC data collection...
...Job Description Job Description Job Summary The Overnight Custodian will be responsible for the overall cleanliness of all areas of the facility to ensure a positive member experience. Essential Duties and Responsibilities Thoroughly clean and sanitize...
...Stagehand - Local 500 - IATSE Responsible for assisting with the assembling, disassembling and operation of stage equipment during production. Essential Duties and Responsibilities Load and unload props and materials from truck dock. Set up lighting, props...
...a skilled leader looking for an opportunity to grow with a supportive company? IHG Mechanical , a renowned provider of industrial refrigeration solutions, is seeking a full-time Industrial Refrigeration Installation Foreman . If you have a strong background in installing...