Entry-Level CMC Regulatory Consultant

BIOLOGICS CONSULTING GROUP INC; Alexandria (VA); On-site; USD 90,000 - 115,000; Full time

Job summary

Biologics Consulting Group, Inc. in the U.S. seeks an Associate Consultant, CMC.

This entry‑level role supports scientific and regulatory project execution through technical writing, research and data analysis, while coordinating activities with project teams. The position focuses on regulatory submissions (Module 3) and proposal development, with emphasis on biotechnology process development and manufacturing. Strong organizational, writing and communication skills are essential.

Qualifications

• Ph.D. in biotechnology/biotech engineering or biochemistry preferred with 1–3 years in process development/manufacturing and technical writing.
• Alternatively, a master's degree with at least three years in manufacturing or process development and related experience.
• Demonstrated interest in product development and regulatory affairs.
• Proficient understanding of biotechnology process development and manufacturing of drug substances/products.
• Experience with analytical assays is a plus.
• Strong written and verbal communication; ability to adapt to scientific/regulatory audiences.
• Experience creating and presenting technical/regulatory documents.

Responsibilities

• Coordinate and manage scientific projects across multiple therapeutic areas.
• Prepare CMC and cGMP technical documents, including regulatory submissions (Module 3), literature reviews, and scientific reports.
• Participate in proposal development to support business growth.
• Pursue knowledge development in regulatory affairs and industry topics.
• Collaborate with cross-functional teams and senior consultants on multiple projects.
• Manage competing priorities and meet deadlines while maintaining quality.
• Demonstrate strong communication and leadership to foster a culture of quality.

Skills

Technical writing

Research

Data analysis

Project coordination

Proposal development

Regulatory affairs

Product development

Communication skills

Team collaboration

Education

Ph.D. in biotechnology/biochemistry

Master's degree in related discipline

Tools

MS Office

Copilot

Job description

Biologics Consulting Group, Inc. in the U.S. seeks an Associate Consultant, CMC.

This entry‑level role supports scientific and regulatory project execution through technical writing, research and data analysis, while coordinating activities with project teams. The position focuses on regulatory submissions (Module 3) and proposal development, with emphasis on biotechnology process development and manufacturing. Strong organizational, writing and communication skills are essential.