Regulatory Affairs Generalist — Hybrid Contract (to 2027)

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

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.