Remote CMC Regulatory Affairs Consultant (Post-Approval)

Parexel; Montpelier (VT); Remote; USD 110,000 - 160,000; 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/Technical Regulatory Specialist) to join our team in a remote capacity. You will support post-approval regulatory activities, shaping CMC regulatory strategy and ensuring submission accuracy across global markets.

You'll collaborate with manufacturing, quality, and supply chain teams, manage regulatory information systems, and contribute to regulatory operations from planning through approval and market expansion.

Qualifications

• Bachelor’s in Chemistry or related life sciences field.
• 5+ years regulatory affairs experience in technical/CMC/quality roles.
• Knowledge of global CMC/post-approval requirements (US, EU, CA, CH, AU, CN, BR).
• Experience writing CMC sections of regulatory documents.
• Previous biologics CMC experience.
• Knowledge of plasma product manufacturing processes is a plus.
• Strong communication, organization, and problem-solving skills.

Responsibilities

• Develop submission strategies for post-approval CMC activities.
• Assess changes and provide regulatory assessments of quality changes.
• Review study reports and quality docs for regulatory compliance.
• Coordinate submission prep with cross-functional teams.
• Write and review submission content aligned with regulations.
• Manage Regulatory Information Management systems across global submissions.
• Identify and mitigate risks in regulatory procedures across markets.

Skills

CMC regulatory strategy

Regulatory affairs experience

Cross-functional collaboration

Attention to detail

RIMS familiarity

Education

Bachelor’s in Chemistry or life sciences

Tools

Veeva Vault

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Parexel is seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) to join our team in a remote capacity. You will support post-approval regulatory activities, shaping CMC regulatory strategy and ensuring submission accuracy across global markets.

You'll collaborate with manufacturing, quality, and supply chain teams, manage regulatory information systems, and contribute to regulatory operations from planning through approval and market expansion.