Remote CMC Regulatory Affairs Consultant – Biologics

Parexel; Annapolis (MD); 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, to lead regulatory strategy for biologics and small molecules. This remote role focuses on US, EU, and Canada submissions, with collaboration across manufacturing, quality, and external partners to ensure compliant, timely approvals.

You will prepare and review CMC/GMP submissions, participate in health authority meetings, and contribute to GRT discussions, leveraging extensive regulatory knowledge and cross-functional

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.
• 4–6 years of CMC experience in the pharmaceutical industry with regulatory filing experience
• Knowledge of GMP, drug development, and regulatory requirements
• Experience preparing CMC (Quality) sections for IND/NDA/DMF submissions for FDA/Europe/Canada
• Regulatory information systems proficiency (Word, Excel, PowerPoint, Outlook)

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules.
• Prepare CMC and GMP documentation for regulatory submissions.
• Represent CMC in project team meetings and provide regulatory guidance.
• Assist in health authority CMC meetings and monthly GRT discussions.
• Collaborate with manufacturing, QA, and external partners on regulatory issues.

Skills

Strategic thinking

Problem solving

Negotiation

Regulatory experience

Cross-functional

Communication

Matrix environment

Education

Bachelor's in Pharmaceutical Sciences or Chemistry, PharmD

Master/PhD preferred

Tools

TrackWise Digital

TRS Viewer

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics, to lead regulatory strategy for biologics and small molecules. This remote role focuses on US, EU, and Canada submissions, with collaboration across manufacturing, quality, and external partners to ensure compliant, timely approvals.

You will prepare and review CMC/GMP submissions, participate in health authority meetings, and contribute to GRT discussions, leveraging extensive regulatory knowledge and cross-functional