Regulatory Affairs Generalist: FDA Submissions & eCTD

Kelly Services; Bridgewater (MA); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

Retirement savings plan

Paid holidays

Job summary

Kelly Science & Clinical is seeking a Regulatory Affairs Generalist for a contract opportunity in the life sciences sector. You will perform hands-on regulatory writing, document review, proofreading, and QC for FDA submissions across IND, NDA, and ANDA products.

The role involves collaborating with Regulatory Affairs leadership and cross-functional experts to ensure submissions are accurate, complete, and compliant with regulatory requirements throughout the lifecycle.

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 U.S. and international regulatory laws, regulations, and guidance.
• Familiarity with U.S. and international regulatory laws, regulations, and guidance.
• Experience with eCTD submission-format requirements and Microsoft Office tools.
• 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 and cross-team collaboration.

Responsibilities

• Prepare, review, proofread, and quality-check components of FDA submissions for IND, NDA, and ANDA products.
• Author regulatory documents, 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 writing

FDA submissions

Attention to detail

Documentation management

Communication skills

Education

Associate degree or higher

Bachelor’s degree preferred

Tools

Microsoft Word

Excel

Adobe Acrobat Pro

eCTD submissions

Documentum

Job description

Kelly Science & Clinical is seeking a Regulatory Affairs Generalist for a contract opportunity in the life sciences sector. You will perform hands-on regulatory writing, document review, proofreading, and QC for FDA submissions across IND, NDA, and ANDA products.

The role involves collaborating with Regulatory Affairs leadership and cross-functional experts to ensure submissions are accurate, complete, and compliant with regulatory requirements throughout the lifecycle.