Remote CMC Regulatory Consultant, Biologics

Parexel; Hartford (CT); Remote; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health 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 join our remote team. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products, with primary responsibility for the US, EU, and Canada to support approvals and continued marketing.

This role offers collaboration with cross-functional teams across manufacturing, quality, and regulatory partners, with opportunities to influence program outcomes and advance

Qualifications

• Bachelor’s degree or higher in a related field required.
• 4–6 years of CMC experience with regulatory filing.
• Knowledge of GMP and the drug development process.
• Experience with biologics and small molecule regulatory filings.
• Proficient with regulatory information systems and submissions.

Responsibilities

• Develop CMC regulatory strategies and contingency plans for biologic and small molecule substances and products.
• Prepare and review CMC and GMP documents for regulatory submissions.
• 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

Cross-functional collaboration

Regulatory affairs awareness

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Pharm.D.

Master's or Ph.D. degree

Tools

TrackWise Digital

TRS Viewer

Microsoft Office

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our remote team. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products, with primary responsibility for the US, EU, and Canada to support approvals and continued marketing.

This role offers collaboration with cross-functional teams across manufacturing, quality, and regulatory partners, with opportunities to influence program outcomes and advance