Remote CMC Regulatory Affairs Specialist

Parexel; Augusta (ME); Remote; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation Time

FSAs

HSA

Work-Life Balance

401(k) 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 and guide CMC regulatory strategy, collaborating with manufacturing, quality, and supply chain teams to ensure submission accuracy.

You will develop strategies, review quality documentation, and manage regulatory information systems to support global submissions and market expansion.

Qualifications

• Bachelor’s degree in Chemistry or Life Sciences.
• 5+ years in regulatory affairs, especially technical/CMC/quality roles.
• Knowledge of global CMC/post-approval regulatory requirements.
• Experience writing CMC sections of regulatory documents.

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 health authority responses.
• Manage Regulatory Information Management systems for global submissions.
• Identify and mitigate regulatory risks across markets.

Skills

CMC regulatory strategy

Post-approval regulatory processes

Quality/technical documentation

Regulatory affairs experience

Cross-team collaboration

Attention to detail

MS Office (Word/PowerPoint/Excel)

Education

Bachelor’s in Chemistry or Life Sciences

Tools

Veeva Vault

Regulatory information systems

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 and guide CMC regulatory strategy, collaborating with manufacturing, quality, and supply chain teams to ensure submission accuracy.

You will develop strategies, review quality documentation, and manage regulatory information systems to support global submissions and market expansion.