Biotech Regulatory Consulting Associate

Biologics Consulting; Alexandria (VA); On-site; USD 90,000 - 115,000; Full time

Job summary

Biologics Consulting is seeking an Associate Consultant (entry level) to support scientific and regulatory project execution in biotechnology. You will contribute to client deliverables through technical writing, literature research, and data analysis, while gaining experience in CMC and regulatory submissions (Module 3).

Working with senior staff across multiple projects, you will develop subject matter expertise, assist in proposal development, and help maintain a culture of quality in service

Qualifications

• Ph.D. in Biotechnology or Biochemistry preferred with 1–3 years in process development or CDMO support.
• Alternatively, a Master’s degree with at least three years of relevant industry/consulting/government experience.
• Demonstrated interest in product development and regulatory affairs.
• Proficient understanding of biotechnology process development and manufacturing.
• Experience reviewing or authoring scientific or regulatory documents.
• Strong verbal and written communication tailored to scientific audiences.

Responsibilities

• Coordinate and manage scientific projects across multiple therapeutic areas.
• Contribute to preparation of CMC and cGMP documents, including Module 3 submissions.
• Support proposal preparation and business development.
• Pursue knowledge development in regulatory affairs and industry topics.
• Collaborate with cross-functional teams and senior consultants.
• Manage competing priorities and meet deadlines while maintaining quality.
• Communicate effectively with scientific and professional audiences.
• Foster a culture of quality in service delivery.

Skills

Scientific writing

Regulatory affairs

Data analysis

Project coordination

Communication skills

PowerPoint presentations

MS Office

Team collaboration

Education

Ph.D. in Biotechnology/Biochemistry

M.S. in related discipline

Tools

Copilot AI tools

MS Office Suite

Job description

Biologics Consulting is seeking an Associate Consultant (entry level) to support scientific and regulatory project execution in biotechnology. You will contribute to client deliverables through technical writing, literature research, and data analysis, while gaining experience in CMC and regulatory submissions (Module 3).

Working with senior staff across multiple projects, you will develop subject matter expertise, assist in proposal development, and help maintain a culture of quality in service