Remote CMC Regulatory Consultant - Post-Approval Expert

Parexel; Helena (MT); Remote; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

Tuition reimbursement

Vacation time

FSA/HSAs

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 strategy and compliance across global markets.

You’ll collaborate with manufacturing, quality, and supply chain to ensure accurate submissions and regulatory success. You’ll have opportunities to deepen expertise in post-approval regulatory affairs, contribute to regulatory operations from submission

Qualifications

• Bachelor’s in Chemistry or a related Life Sciences field.
• 5+ years 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.

Responsibilities

• Develop submission strategies for post-approval CMC activities.
• Assess change controls and provide regulatory assessments of quality changes in production and quality control processes.
• Review study reports and quality documentation to ensure regulatory compliance.
• 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

Regulatory affairs experience

Cross-functional collaboration

Attention to detail

Regulatory information systems

Education

Bachelor’s in Chemistry or Life Sciences

Tools

Veeva Vault

Microsoft Office

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 strategy and compliance across global markets.

You’ll collaborate with manufacturing, quality, and supply chain to ensure accurate submissions and regulatory success. You’ll have opportunities to deepen expertise in post-approval regulatory affairs, contribute to regulatory operations from submission