Remote CMC Regulatory Affairs Consultant, Biologics

Parexel; Providence (RI); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

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 for biologics and small molecule products, ensuring compliance across US, EU, and Canada.

The role collaborates with manufacturing, quality, and cross-functional partners to drive timely approvals and sustained product access. You will engage in preparing CMC and GMP submissions, guiding regulatory strategy from development through post-approval

Qualifications

• Bachelor's degree or Pharm.D. required for regulatory submissions.
• 4–6 years of CMC experience in pharma with filing docs.
• Knowledge of GMP and global regulatory submissions (IND/NDA/DMF).
• Experience with biologics and small molecules regulatory requirements.

Responsibilities

• Develop CMC regulatory strategies and contingency plans for biologics and small molecules.
• Prepare and review CMC/GMP documents for regulatory submissions.
• Represent CMC Regulatory Affairs in project teams and cross-functional meetings.
• Support health authority meetings and monthly CMC GRT meetings.
• Collaborate with manufacturing, quality, and external partners on CMC issues.
• Drive process improvements in local and global CMC regulatory affairs.

Skills

Strategic thinking

Analytical problem solving

Negotiation

Collaborative communication

Regulatory affairs

Multi-project management

Regulatory information systems

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.

Master's or Ph.D. degree (preferred)

Regulatory Affairs Certification (RAC) (preferred)

Tools

TrackWise Digital

TRS Viewer

Microsoft Word/Excel/PowerPoint/Outlook

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 for biologics and small molecule products, ensuring compliance across US, EU, and Canada.

The role collaborates with manufacturing, quality, and cross-functional partners to drive timely approvals and sustained product access. You will engage in preparing CMC and GMP submissions, guiding regulatory strategy from development through post-approval