Remote CMC Regulatory Affairs Consultant - Biologics

Parexel; Topeka (KS); Remote; USD 110,000 - 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, a global clinical development partner, is seeking a Regulatory Affairs Consultant, CMC – Biologics. This remote role focuses on regulatory strategy for biologics and small molecules with primary attention to the US, EU, and Canada to support timely approvals and ongoing compliance.

You will prepare CMC/GMP submissions, collaborate with regulatory leads and cross-functional teams, and contribute from early development through post-approval changes, driving high-quality submissions and

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.
• 4–6 years of CMC experience in pharma with regulatory filings
• Knowledge of global regulatory requirements for biologics and small molecules

Responsibilities

• Develop CMC regulatory strategies and contingency plans for biologics and small molecules
• Prepare, coordinate, and review CMC and GMP documentation for regulatory submissions
• Represent CMC Regulatory Affairs in project team meetings with cross-functional teams
• Support health authority CMC meetings including mock meetings and planning
• Coordinate monthly CMC GRT meetings with global teams
• Interact with manufacturing, quality, and external partners on CMC issues
• Develop and maintain relationships with global functional units and suppliers
• Prepare departmental job procedures
• Identify opportunities to optimize CMC regulatory processes

Skills

Strategic thinking

Analytical skills

Negotiation

Collaboration

Regulatory submissions

Project management

TrackWise Digital

TRS Viewer

Education

Bachelor's in Pharmaceutical Sciences or Chemistry

Pharm.D.

Master's or Ph.D. preferred

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

Parexel, a global clinical development partner, is seeking a Regulatory Affairs Consultant, CMC – Biologics. This remote role focuses on regulatory strategy for biologics and small molecules with primary attention to the US, EU, and Canada to support timely approvals and ongoing compliance.

You will prepare CMC/GMP submissions, collaborate with regulatory leads and cross-functional teams, and contribute from early development through post-approval changes, driving high-quality submissions and