Remote Post-Approval CMC Regulatory Strategist

Parexel; Carson City (NV); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation & Holiday Time

FSA/HSA

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel seeks 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, ensuring compliance, and driving accurate submissions across global markets.

You’ll collaborate with manufacturing, quality, and supply chain partners to plan submissions, assess changes, and manage regulatory information systems, advancing clinical product development and market expansion.

Qualifications

• Bachelor’s in Chemistry or related Life Sciences (required).
• 5+ years in regulatory affairs, with CMC/quality focus.
• Experience with global CMC/post-approval requirements (US, EU, CA, CH, AU, CN, BR).
• Experience writing CMC (technical) sections of regulatory filings.
• Biologics CMC experience is a plus.
• Knowledge of plasma product manufacturing processes a plus.
• Strong communication and problem-solving skills.

Responsibilities

• Develop submission strategies for post-approval CMC activities.
• Assess change controls and regulatory assessments of quality changes.
• Review quality documentation to ensure regulatory compliance.
• Coordinate submission prep with cross-functional teams.
• Write and review submission content for variations and responses.
• Manage Regulatory Information Management systems and submissions.
• Identify and mitigate regulatory risks across global markets.

Skills

CMC strategy

Post-approval regs

Quality documentation

Regulatory affairs

Cross-team collaboration

Regulatory IT systems

Education

Bachelor’s in Chemistry or Life Sciences

Tools

Veeva Vault

Regulatory Information Systems

Job description

Parexel seeks 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, ensuring compliance, and driving accurate submissions across global markets.

You’ll collaborate with manufacturing, quality, and supply chain partners to plan submissions, assess changes, and manage regulatory information systems, advancing clinical product development and market expansion.