Regulatory Affairs Specialist — FDA Submissions & eCTD

Kelly Services; Bridgewater Township (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Kelly Science & Clinical is seeking a Regulatory Affairs Generalist on a contract basis to support FDA submissions and regulatory documentation. You will perform hands-on regulatory writing, document review, proofreading, and quality-control for IND, NDA, and ANDA products, collaborating with cross‑functional SMEs and Regulatory Affairs leadership.

The role involves preparing submission components, ensuring compliance with regulatory requirements, and delivering submission-ready documents for

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.
• Experience with Microsoft Word, Excel, Adobe Acrobat Pro, and eCTD submission‑format requirements.
• 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.

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.

Skills

Regulatory affairs

Medical writing

GxP understanding

eCTD knowledge

Education

Associate degree

Bachelor's degree

Tools

Microsoft Word

Excel

Adobe Acrobat Pro

Documentum

eCTD submission tools

Job description

Kelly Science & Clinical is seeking a Regulatory Affairs Generalist on a contract basis to support FDA submissions and regulatory documentation. You will perform hands-on regulatory writing, document review, proofreading, and quality-control for IND, NDA, and ANDA products, collaborating with cross‑functional SMEs and Regulatory Affairs leadership.

The role involves preparing submission components, ensuring compliance with regulatory requirements, and delivering submission-ready documents for