Regulatory Affairs Generalist

Spectraforce; Bridgewater Township (NJ); Hybrid; USD 42,000 - 60,000; Full time

Benefits offered by this job

Hybrid work schedule

Job summary

Spectraforce is seeking a Regulatory Affairs Generalist for a hybrid, 12-month assignment. Ideal candidates will have experience preparing FDA submissions and maintaining regulatory compliance in a fast-paced environment.

You will review and assemble FDA submission components, author supporting docs, and collaborate with Regulatory Management to ensure alignment with regulatory requirements. E-publishing and eCTD readiness are key deliverables.

Qualifications

• Associate degree required; Bachelor’s preferred or equivalent experience.
• 1.5 years Regulatory Affairs experience or in a regulated environment.
• Proficient with Word, Excel, Adobe Acrobat Pro, eCTD and document management systems.

Responsibilities

• Review, proofreading, and QA of FDA submission components for IND, NDA, ANDA.
• Author and support regulatory documents including cover letters and FDA forms.
• Prepare modular submission content from nonclinical, clinical, and medical affairs SMEs.

Skills

Attention to detail

Regulatory knowledge

Communication skills

Documentation

Education

Associate degree

Bachelor’s degree preferred

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat Pro

eCTD submission

Documentum

Job description

Position Title: Regulatory Affairs Generalist

Assignment Duration: 12 Months

Work Arrangement: Hybrid

• Hybrid work schedule—enjoy both onsite and remote flexibility
• Long-term contract opportunity through the end of 2027

Position Summary:

If you’re experienced in preparing FDA submission materials, committed to accuracy and regulatory compliance, and thrive in a fast-paced, professional environment.

Key Responsibilities:

• Reviewing, proofreading, and quality-checking FDA submission components for IND, NDA, and ANDA products
• Authoring and supporting regulatory documentation, including cover letters, FDA forms, Module 1 documents, annual reports, labeling, non-CMC supplements, and product correspondence
• Preparing and reviewing modular submission content from nonclinical, clinical, and medical affairs subject matter experts
• Collaborating with Regulatory Management to ensure product documentation aligns with regulatory requirements
• Supporting preparation of materials for regulatory authority interactions
• Delivering final submission-ready documents for e-publishing and eCTD format submission
• Communicating progress, potential risks, and regulatory concerns to Regulatory Product Leads and/or Regulatory Affairs leadership
• Contributing to special projects and continuous process-improvement initiatives as assigned

Qualification & Experience:

• Have at least an Associate degree; Bachelor’s degree is preferred or equivalent relevant experience
• Possess a minimum of 1.5 years of Regulatory Affairs experience or experience in a regulated environment
• Demonstrate working knowledge of pharmaceutical Regulatory Affairs across development, labeling, and post-market activities
• Are familiar with domestic and international regulatory laws, regulations, and guidance
• Understand clinical development and regulatory requirements for development milestones and market authorization
• Are proficient with Microsoft Word, Excel, Adobe Acrobat Pro, eCTD submission-format requirements, and controlled document management systems (Documentum experience preferred)
• Have excellent attention to detail, proofreading, analytical reasoning, and critical-thinking skills
• Communicate clearly both in writing and verbally, and collaborate effectively across teams
• Can assess project risks, elevate concerns appropriately, and respond decisively in changing circumstances

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. The pay rate for this position is $37.00/hr.