Regulatory Affairs Generalist

Spectraforce Technologies, Inc.; Bridgewater Township (NJ); Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Hybrid work schedule-enjoy both onsite

Long-term contract opportunity through

Job summary

Spectraforce Technologies, Inc. is seeking a Regulatory Affairs Generalist for a 2-month hybrid role in Bridgewater, NJ. The candidate will prepare FDA submission materials, ensure regulatory compliance, and support cross-functional teams in a fast-paced setting.

Responsibilities include drafting documents, coordinating with subject matter experts, and delivering submission-ready materials for eCTD. Strong attention to detail and MS Office proficiency are required.

Qualifications

• Have at least an Associate degree; Bachelor's degree preferred or equivalent experience.
• 1.5 years Regulatory Affairs or regulated environment experience.
• Familiar with domestic and international regulatory laws and guidance.
• Proficient with MS Word, Excel, Acrobat Pro, eCTD and document control systems.

Responsibilities

• Review FDA submission components for IND, NDA, ANDA products.
• Authorize regulatory documentation including cover letters and forms.
• Prepare modules from nonclinical, clinical, and medical affairs experts.
• Collaborate to ensure documents meet regulatory requirements.
• Support materials for regulatory authority interactions.
• Deliver final submission-ready e-pub and eCTD content.

Skills

Attention to detail

Analytical reasoning

Written and verbal communication

Regulatory affairs knowledge

Education

Associate degree

Bachelor's degree preferred

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat Pro

eCTD submission format

Documentum

Job description

Position Title: Regulatory Affairs Generalist

Work Location: Bridgewater, NJ

Assignment Duration: 2 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, **escalate** concerns appropriately, and respond decisively in changing circumstances