CMC Biologics Regulatory Consultant (Remote)

Parexel; Frankfort (KY); Remote; USD 110,000 - 165,000; 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. You will provide CMC regulatory strategy input for biologics and small molecules, supporting US, EU, and Canada submissions and post‑approval changes.

In this fast‑paced role you will prepare CMC/GMP documentation, collaborate with global teams, and contribute to health authority meetings. A background in pharma regulatory affairs with TrackWise experience is ideal.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or Chemistry or Pharm.D.
• 4–6 years of CMC experience in pharma with regulatory filing experience
• Knowledge of CMC regulatory requirements for biologics and small molecules
• Experience preparing CMC sections for FDA/EC submissions and post‑approval changes
• Regulatory submissions preparation using GMP/regulatory standards
• Strong communication, negotiation, and project coordination skills
• Proficiency with TrackWise and regulatory information systems

Responsibilities

• Develop and implement CMC regulatory strategies for biologics and small molecules.
• Prepare, coordinate, and review CMC/GMP documents for regulatory submissions.
• Represent CMC Regulatory Affairs in cross‑functional project teams.
• Support health authority meetings and monthly CMC GRT meetings.
• Interact with manufacturing, quality, and external partners on CMC issues.
• Prepare departmental job procedures and optimize regulatory processes.

Skills

CMC Regulatory Affairs

Regulatory Strategy

GMP/Regulatory Knowledge

Document Management

Cross-functional Collaboration

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Pharm.D. preferred

Tools

TrackWise

TRS Viewer

MS 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 biologics and small molecules, supporting US, EU, and Canada submissions and post‑approval changes.

In this fast‑paced role you will prepare CMC/GMP documentation, collaborate with global teams, and contribute to health authority meetings. A background in pharma regulatory affairs with TrackWise experience is ideal.