Remote CMC Regulatory Affairs Consultant

Parexel International; United States; Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation Time

Flexible Spending Accounts

Life Insurance

401(k) with Company match

Pet Insurance

Job summary

Parexel International is seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) to support post-approval regulatory activities in a remote capacity. You will contribute to CMC regulatory strategy, compliance oversight, and submission accuracy across global markets, collaborating with manufacturing, QA, and supply chain teams.

The role offers diverse learning opportunities in regulatory affairs, quality, and clinical development within a fast-paced, growth-oriented

Qualifications

• Bachelor’s in Chemistry or Life Sciences.
• 5+ years of regulatory affairs experience in technical/CMC/quality roles.
• Strong understanding of global CMC/post-approval requirements (US/EU/CA/CH/AU/CN/BR).
• Experience writing CMC (technical) sections for registration files or variations.
• Biologics CMC experience is a plus.

Responsibilities

• Develop submission strategies for post-approval CMC activities (variations, renewals, market expansions, annual reports).
• Assess change controls and provide regulatory assessments of quality changes.
• Review study reports and quality documentation to ensure regulatory compliance.
• Coordinate submission preparation with cross-functional teams (manufacturing, supply chain, quality control).
• Write and review submission content to align with regulatory requirements for variations and health authority responses.
• Manage Regulatory Information Management systems and worldwide submissions.

Skills

CMC regulatory strategy

Post-approval regulatory

Quality documentation

Cross-functional collaboration

Regulatory information systems

Regulatory communications

Education

Bachelor’s in Chemistry or Life Sciences

Tools

Veeva Vault

Job description

Parexel International is seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) to support post-approval regulatory activities in a remote capacity. You will contribute to CMC regulatory strategy, compliance oversight, and submission accuracy across global markets, collaborating with manufacturing, QA, and supply chain teams.

The role offers diverse learning opportunities in regulatory affairs, quality, and clinical development within a fast-paced, growth-oriented