Title: Sr Regulatory Writer – R&D, CMC Location: Bergen County, NJ Schedule: M-F Full Hybrid, Thursday & Friday Remote Type: Direct Hire About the Role We are seeking a Senior Regulatory Writer with a strong foundation in CMC (Chemistry, Manufacturing, and Controls) and small molecule development to support a diverse product pipeline that spans pharmaceuticals, combination products, and consumer health solutions. This role plays a critical part in driving regulatory documentation across the product lifecycle—particularly for CMC components of regulatory submissions (Module 3)—in support of U.S. and global filings. The ideal candidate brings a blend of scientific writing expertise, deep familiarity with drug substance and drug product development, and the ability to work cross-functionally with subject matter experts to deliver high-quality documentation aligned with regulatory strategy and development timelines. Key Responsibilities + Serve as a lead CMC writer for regulatory documents supporting development and registration of small molecule and combination drug/device products. + Author and compile high-quality Module 3 content (CMC sections) for regulatory submissions (IND, NDA, ANDA), collaborating with SMEs including analytical chemists, formulation scientists, and process engineers. + Prepare technical content for investigator brochures, FDA briefing packages, eCTD summaries, and other regulatory documents across global markets. Qualifications + Advanced degree in a scientific discipline (PhD preferred); BS/MS with extensive relevant experience will be considered. + 3+ years (PhD) or 7+ years (BS/MS) of regulatory or technical writing experience in the pharmaceutical, biotech, or life sciences industries. + Demonstrated experience in authoring CMC documentation for small molecules (required); device experience a plus. + Deep understanding of drug development workflows including synthesis, impurity profiling, reference standards, analytical methods, and stability testing. + Familiarity with eCTD submissions and document management systems. + Working knowledge of laboratory procedures (analytical, microbiological) and scientific terminology. + Highly proficient in MS Word, Excel, and other standard documentation tools. #M3- #LI- #DI- Ref: #558-Scientific System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.