CMC Regulatory Strategy Lead

BIOLOGICS CONSULTING GROUP INC; Alexandria (VA); On-site; USD 160,000 - 185,000; Full time

Job summary

BIOLOGICS CONSULTING GROUP INC. seeks a Senior Consultant, CMC to lead complex CMC and FDA regulatory consulting projects in the US. The role requires directing project work, mentoring junior staff, and strengthening client partnerships while driving quality and growth.

The incumbent will act as a senior project leader, ensuring delivery of regulatory documents, technical reports, and literature reviews, with a focus on client satisfaction and business development.

Qualifications

• Ph.D. in biotechnology or related field with 5-7 years of industry, consulting, and/or FDA experience.
• Experience with biomanufacturing and regulatory interactions is strongly preferred.
• Proven ability to lead scientific projects and manage client engagements independently.

Responsibilities

• Lead CMC regulatory and scientific consulting projects for clients.
• Manage client relationships and provide oversight on project delivery.
• Mentor junior staff and contribute to professional development.
• Support business development and proposal activities.
• Ensure high-quality, compliant deliverables and effective project execution.

Skills

Leadership

Scientific writing

Regulatory knowledge

Client relationship management

Mentoring

Education

Ph.D. in biotechnology or related field

M.S. in related disciplines (with 10+ years experience)

Tools

Microsoft Office Suite

Job description

BIOLOGICS CONSULTING GROUP INC. seeks a Senior Consultant, CMC to lead complex CMC and FDA regulatory consulting projects in the US. The role requires directing project work, mentoring junior staff, and strengthening client partnerships while driving quality and growth.

The incumbent will act as a senior project leader, ensuring delivery of regulatory documents, technical reports, and literature reviews, with a focus on client satisfaction and business development.