Remote CMC Regulatory Strategist

Parexel; Cheyenne (WY); Remote; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Vision insurance

Dental insurance

Tuition reimbursement

401(k) with company match

Flexible spending accounts

Vacation/Holiday/Sick time

Pet insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant to work remotely. You will support post-approval regulatory activities to advance new treatments for patients.

Your responsibilities will include developing CMC submission strategies, assessing change controls, and managing regulatory information systems. The role requires a Bachelor’s in Chemistry or a related field and 5+ years of experience in regulatory affairs, particularly within the pharmaceutical industry.

Qualifications

• 5+ years of experience in regulatory affairs, particularly in technical/CMC/quality regulatory roles.
• Strong understanding of CMC and post-approval regulatory requirements for global markets.
• Experience in writing CMC sections of regulatory documents.

Responsibilities

• Develop submission strategies for post-approval CMC activities.
• Assess change controls and provide regulatory assessments.
• Review quality documentation from manufacturing departments.

Skills

CMC regulatory strategy

Post-approval regulatory processes

Quality documentation

Regulatory information management

Communication skills

Attention to detail

Education

Bachelor’s in Chemistry or related field

Tools

Word

PowerPoint

Excel

Veeva Vault

Job description

Parexel is seeking a Regulatory Affairs Consultant to work remotely. You will support post-approval regulatory activities to advance new treatments for patients.

Your responsibilities will include developing CMC submission strategies, assessing change controls, and managing regulatory information systems. The role requires a Bachelor’s in Chemistry or a related field and 5+ years of experience in regulatory affairs, particularly within the pharmaceutical industry.