Remote CMC Regulatory Affairs Consultant

Parexel; Honolulu (HI); Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Paid Time Off

FSA/HSAs

Work-Life Balance

401(k) Match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) for remote work. You will support post‑approval regulatory activities, shaping CMC strategy, ensuring submission accuracy, and collaborating with manufacturing, quality, and supply chain teams to enable global market expansion.

The role emphasizes experience with global regulatory requirements, post-approval processes, and quality documentation, with opportunities to grow across regulatory affairs and

Qualifications

• 5+ years of experience in regulatory affairs, particularly in technical/CMC/quality regulatory roles within the pharmaceutical industry
• Strong understanding of global CMC and post-approval regulatory requirements (US, EU, CA, CH, AU, CN, BR)
• Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
• Previous biologics regulatory CMC experience
• Knowledge of plasma product manufacturing processes and regulatory requirements is a plus
• Strong communication, organization, and problem-solving skills

Responsibilities

• Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
• Assess change controls and provide regulatory assessments of quality changes in production and quality control processes
• Review study reports and quality documentation from manufacturing and quality control departments to ensure compliance with regulatory requirements
• Coordinate submission preparation with cross-functional teams including manufacturing, supply chain, quality control, quality assurance, and other regulatory departments
• Write and review submission content to ensure alignment with regulatory requirements, specifically related to variations and responses to health authority questions
• Manage projects within Regulatory Information Management systems, ensuring the maintenance and accuracy of worldwide submissions
• Identify, escalation, and mitigate risks associated with regulatory procedures and activities across global markets

Skills

CMC regulatory strategy

Post-approval processes

Quality/technical documentation

Regulatory information systems

Cross-functional collaboration

Education

Bachelor’s in Chemistry or Life Sciences

Tools

Veeva Vault

Job description

Parexel is seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) for remote work. You will support post‑approval regulatory activities, shaping CMC strategy, ensuring submission accuracy, and collaborating with manufacturing, quality, and supply chain teams to enable global market expansion.

The role emphasizes experience with global regulatory requirements, post-approval processes, and quality documentation, with opportunities to grow across regulatory affairs and