Remote CMC Regulatory Affairs Consultant (Post-Approval)

Parexel; Boise (ID); Remote; USD 95,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Tuition reimbursement

Vacation & sick time

401(k) with company match

Pet insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant (CMC/Technical Regulatory Specialist) for a remote role to support post‑approval regulatory activities and CMC strategies across global markets.

You will collaborate with manufacturing, quality, and supply chain teams to ensure submission accuracy and regulatory compliance, with opportunities to deepen expertise in regulatory operations and product development.

Qualifications

• Experience in regulatory affairs with technical/CMC focus.
• Global CMC post-approval regulatory knowledge for US/EU/other markets.
• Experience writing CMC sections of regulatory documents.
• Biologics CMC experience is a plus.

Responsibilities

• Develop submission strategies for post‑approval CMC activities.
• Review quality documentation and study reports for regulatory compliance.
• Coordinate submissions with cross‑functional teams (manufacturing, QA, supply chain).
• Maintain regulatory information systems and worldwide submissions.
• Identify risks and provide regulatory assessments across markets.

Skills

CMC regulatory strategy

Post-approval processes

Quality documentation

Regulatory affairs

Cross-functional collaboration

Regulatory information mgmt

MS Office (Word, PPT, Excel)

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) for a remote role to support post‑approval regulatory activities and CMC strategies across global markets.

You will collaborate with manufacturing, quality, and supply chain teams to ensure submission accuracy and regulatory compliance, with opportunities to deepen expertise in regulatory operations and product development.