Remote CMC Regulatory Consultant, Biologics

Parexel; Lansing (MI); 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 drive regulatory strategy for biologic and small molecule products. The role focuses on US, EU, and Canada submissions, with remote capacity and cross-functional collaboration across manufacturing, quality, and regulatory teams.

You will prepare CMC/GMP documents, participate in health authority meetings, and support post-approval changes while advancing fast, compliant submissions and continuous process improvements within a

Qualifications

• 4–6 years CMC experience with regulatory filing documents.
• Knowledge of GMP and drug development pathways.
• Understanding of CMC regulatory expectations for biologics and small molecules.

Responsibilities

• Develop CMC regulatory strategies and contingency plans for biologics and small molecules.
• Prepare and review CMC/GMP documents for regulatory submissions.
• Support health authority meetings and cross-functional project teams.
• Coordinate with manufacturing, quality, and global regulatory leads.
• Contribute to regulatory strategy for development through post-approval changes.
• Represent CMC in project team discussions and regulatory meetings.

Skills

Strategic thinking

Analytical

Negotiation

Collab & comms

Multi-project

Regulatory systems

Education

Bachelor's in Pharmaceutical Sciences/Chemistry or Pharm.D.

Master's/Ph.D. in related field

Tools

Trackwise Digital

TRS Viewer

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to drive regulatory strategy for biologic and small molecule products. The role focuses on US, EU, and Canada submissions, with remote capacity and cross-functional collaboration across manufacturing, quality, and regulatory teams.

You will prepare CMC/GMP documents, participate in health authority meetings, and support post-approval changes while advancing fast, compliant submissions and continuous process improvements within a