Remote CMC Biologics Regulatory Affairs Consultant

Parexel; United States; Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

FSA/HSA

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel seeks a Regulatory Affairs Consultant, CMC – Biologics for a remote role focused on US, EU, and Canada. You will provide CMC regulatory strategy input for biologics and small molecules, ensuring compliance across global regulatory requirements and guiding submissions from development through post-approval changes.

You will collaborate with cross-functional teams, prepare CMC/GMP documents, support health authority meetings, and contribute to process improvements in a fast-paced clinical

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 GMP, drug development processes, and global regulatory requirements
• Experience preparing CMC sections for IND/NDA/DMF submissions

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules.
• Prepare and review CMC and GMP submission documents.
• Represent CMC Regulatory Affairs in project teams and meetings.
• Support health authority CMC meetings and monthly GRT meetings.
• Collaborate with manufacturing, quality, and external partners on CMC issues.

Skills

Strategic thinking

Analytical problem solving

Negotiation

Collaborative communication

Regulatory submissions

Project management

Education

Bachelor's in Pharmaceutical Sciences or Chemistry

Pharm.D.

Tools

TrackWise Digital

TRS Viewer

Microsoft Word/Excel/PowerPoint/Outlook

Internal regulatory systems

Job description

Parexel seeks a Regulatory Affairs Consultant, CMC – Biologics for a remote role focused on US, EU, and Canada. You will provide CMC regulatory strategy input for biologics and small molecules, ensuring compliance across global regulatory requirements and guiding submissions from development through post-approval changes.

You will collaborate with cross-functional teams, prepare CMC/GMP documents, support health authority meetings, and contribute to process improvements in a fast-paced clinical