CMC Regulatory Scientist I — Submissions & Compliance

Spectraforce Technologies; Rahway (NJ); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies is seeking a CMC Regulatory Scientist I for a 6+ month assignment in Rahway, NJ. The hybrid role combines on‑site and remote work with a focus on developing regulatory submission strategies and drafting CMC dossiers.

The successful candidate will have a BS in a scientific field, at least 2 years of related experience, and strong English communication. You will work with cross‑functional teams to ensure timely registrations and compliance across global markets.

Qualifications

• Bachelor of Science in science, engineering, or related field (advanced degree preferred).
• Minimum 2 years of relevant experience in pharma/CMC or manufacturing/quality.
• Strong English, professional communication, and cross‑functional collaboration.

Responsibilities

• Develop CMC regulatory submission strategies and timelines for projects.
• Prepare and review regulatory CMC dossiers for new and existing products.
• Coordinate with global regulators to manage renewals, variations, and responses to authority questions.
• Assess post‑approval changes and drafting strategies with timelines and risk mitigation.
• Maintain regulatory information to support compliance and registrations.
• Share knowledge of CMC regulations and guidelines (FDA, EMA, VICH).
• Identify regulatory issues early and communicate with management.
• Collaborate with product development teams to meet milestones.

Skills

English proficiency

Leadership

Communication

Prioritization

Problem solving

Attention to detail

Education

Bachelor's degree

Job description

Spectraforce Technologies is seeking a CMC Regulatory Scientist I for a 6+ month assignment in Rahway, NJ. The hybrid role combines on‑site and remote work with a focus on developing regulatory submission strategies and drafting CMC dossiers.

The successful candidate will have a BS in a scientific field, at least 2 years of related experience, and strong English communication. You will work with cross‑functional teams to ensure timely registrations and compliance across global markets.