Remote CMC Regulatory Affairs Consultant – Biologics

Parexel; Columbus (OH); Remote; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule drug products, focusing on the US, EU, and Canada to support timely approvals and ongoing marketing.

This role involves preparing CMC and GMP documentation, collaborating with cross-functional teams, and contributing to regulatory strategy from development through post-approval

Qualifications

• Bachelor's degree in pharmaceutical sciences, chemistry, or Pharm.D.
• 4–6 years of CMC experience in pharma
• Knowledge of GMP, drug development, and global regulatory requirements
• Experience preparing CMC (Quality) sections for IND/NDA/DMF submissions
• Strong regulatory writing and communication skills

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules
• Prepare and review CMC and GMP documents for submissions
• Represent CMC Regulatory Affairs in project teams
• Support health authority meetings and monthly CMC GRT meetings
• Collaborate with manufacturing, QA, and external partners
• Draft departmental procedures and drive process improvements

Skills

Strategic thinking

Analytical problem solving

Negotiation

Education

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

Tools

Microsoft Office

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule drug products, focusing on the US, EU, and Canada to support timely approvals and ongoing marketing.

This role involves preparing CMC and GMP documentation, collaborating with cross-functional teams, and contributing to regulatory strategy from development through post-approval