Remote CMC Regulatory Affairs Consultant - Biologics

Parexel; Olympia (WA); Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. The role provides CMC regulatory strategy input for biologic and small molecule products, with primary responsibility for the US, EU, and Canada to support timely approvals.

You will prepare and review CMC and GMP documentation, collaborate across manufacturing, quality, and regulatory teams, and contribute to global regulatory strategy from development through post-approval changes.

Qualifications

• 4–6 years of CMC experience in pharma with regulatory filing experience.
• Comprehensive knowledge of drug development, GMP, and regulatory expectations.
• Experience in preparing CMC sections for IND/NDA/DMF submissions.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules across development stages.
• Prepare and review CMC/GMP documents for regulatory submissions.
• Represent CMC Regulatory Affairs in cross-functional project meetings.

Skills

Strategic thinking

Analytical problem solving

Negotiation

Regulatory collaboration

Presentation skills

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Pharm.D.

Tools

TrackWise Digital

TRS Viewer

Microsoft Office

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. The role provides CMC regulatory strategy input for biologic and small molecule products, with primary responsibility for the US, EU, and Canada to support timely approvals.

You will prepare and review CMC and GMP documentation, collaborate across manufacturing, quality, and regulatory teams, and contribute to global regulatory strategy from development through post-approval changes.