Remote CMC Regulatory Affairs Consultant – Biologics

Parexel; Cheyenne (WY); Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Health Insurance

Vision Insurance

Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending Account

Health Savings Account

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is a leading global clinical development partner seeking a Regulatory Affairs Consultant, CMC – Biologics for a remote role. You will shape CMC regulatory strategy for biologics and small molecules and support global submissions to US, EU, and Canada.

The position emphasizes collaboration across manufacturing, quality, and cross-functional teams to ensure timely approvals. The role involves preparing regulatory documentation, participating in regulatory strategy from development through

Qualifications

• 4-6 years of CMC experience in the pharmaceutical industry with regulatory filing expertise.
• Comprehensive knowledge of drug development, GMP, and regulatory requirements.
• Experience preparing CMC sections for IND, NDA, DMF submissions (FDA and global).
• Global regulatory environment understanding and ability to work cross-region.
• Proficiency with document management and regulatory information systems.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecules.
• Prepare and review CMC and GMP documents for regulatory submissions.
• Represent CMC Regulatory Affairs in project team meetings.
• Support health authority meetings planning and post-approval changes.
• Collaborate with manufacturing, quality, and external partners on CMC issues.
• Contribute to regulatory process improvements and efficiency initiatives.

Skills

Analytical thinking

Problem-solving

Negotiation

Communication skills

Cross-cultural collaboration

Matrix leadership

Regulatory affairs knowledge

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

Parexel is a leading global clinical development partner seeking a Regulatory Affairs Consultant, CMC – Biologics for a remote role. You will shape CMC regulatory strategy for biologics and small molecules and support global submissions to US, EU, and Canada.

The position emphasizes collaboration across manufacturing, quality, and cross-functional teams to ensure timely approvals. The role involves preparing regulatory documentation, participating in regulatory strategy from development through