Remote CMC Regulatory Affairs Specialist

Parexel; Salt Lake City (UT); Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Life Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) to support post-approval regulatory activities in a remote capacity. You will shape CMC regulatory strategy, oversee compliance, and ensure accurate regulatory submissions across global markets.

You will collaborate with manufacturing, quality, and supply chain teams while contributing to regulatory operations from planning through approval and market expansion, with opportunities to grow in post-approval

Qualifications

• Bachelor’s degree in Chemistry or a related Life Sciences field.
• 5+ years of experience in regulatory affairs, particularly in technical/CMC/quality regulatory roles within the pharmaceutical industry.
• Strong understanding of CMC and post-approval regulatory requirements for global markets (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 regulatory

Quality documentation

Cross-functional collaboration

Regulatory information systems

Education

Bachelor’s in Chemistry or Life Sciences

Tools

Veeva Vault

Regulatory Information Management Systems

Job description

Parexel is seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) to support post-approval regulatory activities in a remote capacity. You will shape CMC regulatory strategy, oversee compliance, and ensure accurate regulatory submissions across global markets.

You will collaborate with manufacturing, quality, and supply chain teams while contributing to regulatory operations from planning through approval and market expansion, with opportunities to grow in post-approval