Remote CMC Regulatory Affairs Consultant – Biologics

Parexel; Montpelier (VT); Remote; USD 120,000 - 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, for a remote-capable position focused on regulatory strategy input for biologics and small molecules. You will support US, EU, and Canada submissions, collaborating across manufacturing, quality, and regulatory teams to ensure compliant, timely approvals.

The role emphasizes preparing CMC/GMP documents, participating in health authority meetings, and driving continuous improvements in regulatory processes.

Qualifications

• Bachelor's in pharmaceutical sciences/chemistry or Pharm.D. required.
• 4–6 years CMC experience in pharma regulatory filings.
• Knowledge of GMP, drug development, and global regulatory requirements.

Responsibilities

• Prepare, coordinate, and review CMC and GMP documents for regulatory submissions.
• Represent CMC Regulatory Affairs in project team meetings.
• Support health authority CMC meetings and monthly CMC GRT meetings.
• Interact with manufacturing and quality groups and external partners on CMC issues.
• Develop and maintain relationships with global regulatory units and suppliers.
• Prepare departmental job procedures and drive process improvements.

Skills

Proactive strategic thinking

Analytical problem solving

Negotiation skills

Collaborative communication

Matrixed environment work

Project prioritization

Regulatory information systems

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.

Tools

Trackwise Digital

TRS Viewer

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics, for a remote-capable position focused on regulatory strategy input for biologics and small molecules. You will support US, EU, and Canada submissions, collaborating across manufacturing, quality, and regulatory teams to ensure compliant, timely approvals.

The role emphasizes preparing CMC/GMP documents, participating in health authority meetings, and driving continuous improvements in regulatory processes.