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Regulatory Affairs Generalist at Kelly Science, Engineering, Technology & Telecom Regulatory Affairs Generalist at Kelly Science, Engineering, Technology & Telecom in Somerville, New Jersey Posted in about 9 hours ago.

Type:

full-time

Location:

Bridgewater, NJ Kelly® Science & Clinical is seeking a Regulatory Affairs Generalist for a contract opportunity supporting our client in the life sciences industry. If you're experienced in preparing FDA submission materials, committed to accuracy and regulatory compliance, and thrive in a fast-paced, professional environment, trust The Experts at Hiring Experts to guide your next career move. Position Overview In this role, you will provide hands-on regulatory writing, document review, proofreading, and quality-control support for FDA submissions across investigational and marketed products. You will collaborate with Regulatory Affairs leadership and cross-functional subject matter experts to help ensure submission documents are accurate, complete, and prepared in accordance with applicable regulatory requirements. Key Responsibilities Prepare, review, proofread, and quality-check components of FDA submissions for IND, NDA, and ANDA products. Author and support regulatory documentation, including cover letters, FDA forms, Module 1 documents, annual reports, labeling, non-CMC supplements, and product correspondence. Support development of modular submission content contributed by nonclinical, clinical, medical affairs, and other subject matter experts. Partner with Regulatory Management to ensure product documentation aligns with regulatory requirements throughout the product lifecycle. Assist with documentation and materials required for interactions with regulatory authorities. Deliver final submission-ready documents to Regulatory Operations for e-publishing and submission in eCTD format . Communicate progress, potential timeline risks, and regulatory concerns to Regulatory Product Leads and/or Regulatory Affairs leadership. Contribute to special projects and continuous process-improvement initiatives as assigned. Qualifications Associate degree required; bachelor's degree preferred, or equivalent relevant experience. At least 1.5 years of Regulatory Affairs experience or relevant experience in a regulated environment. Working knowledge of pharmaceutical Regulatory Affairs across product development, labeling, and post-market activities. Familiarity with U.S. and international regulatory laws, regulations, and guidance. Understanding of clinical development and regulatory requirements supporting development milestones and market authorization. Experience with Microsoft Word, Excel, Adobe Acrobat Pro, and eCTD submission-format requirements. Experience with a controlled document management system; Documentum experience is preferred . Strong attention to detail, proofreading ability, analytical reasoning, and critical-thinking skills. Clear written and verbal communication skills, with the ability to collaborate effectively across teams. Ability to assess project risks, escalate concerns appropriately, and respond decisively in changing circumstances. Interested candidates should apply directly to this job posting. Please do not send an email or InMail.