Regulatory CMC Writers

Discover International; United States; On-site; USD 110,000 - 170,000; Full time

Job summary

Discover International seeks Regulatory Affairs CMC Writers in the United States to support the development and commercialization of radiopharmaceutical and biopharmaceutical products. You will author CMC dossiers, including eCTD Module 3 Sections 3.2.S and 3.2.P, and prepare high-quality content for Drug Substance and Drug Product.

The role requires strong knowledge of Quality/CMC regulatory requirements, collaboration across R&D and Regulatory teams, and experience with Veeva for document

Qualifications

• Experience in Regulatory Affairs CMC writing and submission.
• Proficient in eCTD Module 3 authoring for drug substance and drug product.
• Strong ability to translate scientific information into regulatory language.

Responsibilities

• Author and develop CMC 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.
• Ensure submission-ready documentation aligned with Quality/CMC requirements.
• Collaborate with CMC, Quality, Analytical, Manufacturing, and Regulatory teams.
• Maintain consistency, accuracy, and traceability across Module 3 documentation.
• Support dossier preparation, reviews, updates, and revisions.
• Demonstrate strong scientific knowledge and clear regulatory language.

Skills

Regulatory writing

eCTD Module 3

Veeva experience

Cross-functional collaboration

Tools

Veeva

Job description

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.