Remote CMC Regulatory Affairs Consultant, Biologics

Parexel; Austin (TX); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for biologics and small molecule products, focusing on the US, EU, and Canada to support timely approvals and continued marketing.

The role involves preparing CMC and GMP documentation, coordinating with cross-functional teams, leading regulatory guidance, and contributing to regulatory strategy from development through post-approval changes.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.
• 4–6 years of CMC experience in the pharmaceutical industry with a history of preparing regulatory filings
• Knowledge of GMP and drug development processes and related issues
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval
• Experience preparing CMC (Quality) sections for IND, NDA, DMF for FDA and equivalents in Europe and Canada
• Strong understanding of global regulatory environments
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook
• Strong analytical, problem-solving, organizational, and negotiation skills

Responsibilities

• Develop CMC regulatory strategies and contingency plans for biologics and small molecule substances and products
• Develop CMC regulatory strategies for development-phase products and post-approval changes
• Determine regulatory and technical requirements for CMC and GMP-related submissions
• Prepare, coordinate, and review CMC and GMP documents for regulatory submissions
• Represent CMC Regulatory Affairs in project teams and provide regulatory guidance
• Prepare for health authority CMC meetings and support meetings planning
• Support monthly CMC GRT meetings with cross-functional teams
• Interact with manufacturing and quality groups and external partners on CMC issues
• Build and maintain relationships with global units and vendors
• Prepare departmental job procedures
• Identify and implement improvements to CMC regulatory processes

Skills

Strategic thinking

Analytical problem solving

Negotiation

Collaborative communication

Presentation skills

Matrixed environment collaboration

Regulatory affairs expertise

Education

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

Master's or Ph.D. in related field (preferred)

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Trackwise Digital

TRS Viewer

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input for biologics and small molecule products, focusing on the US, EU, and Canada to support timely approvals and continued marketing.

The role involves preparing CMC and GMP documentation, coordinating with cross-functional teams, leading regulatory guidance, and contributing to regulatory strategy from development through post-approval changes.