Remote CMC Biologics Regulatory Consultant

Parexel; Boston (MA); 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 remote team. The role centers on providing CMC regulatory strategy input for biologic and small molecule products, focusing on the US, EU, and Canada.

You will craft and review CMC and GMP documentation, participate in health authority interactions, and collaborate across manufacturing, quality, and global partners. You will work in a fast-paced environment that emphasizes high-quality submissions and continuous

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 filing documentation
• Knowledge of GMP and drug development, regulatory processes
• Knowledge of CMC regulatory requirements for biologics and small molecules
• Experience preparing CMC (Quality) sections for IND, NDA, DMF for FDA/Europe/Canada
• Understanding of global regulatory environment
• Experience with Trackwise Digital and TRS Viewer
• Strong analytical, problem-solving, organizational, and negotiation skills

Responsibilities

• Develop and implement CMC regulatory strategies for biologics and small molecules
• Prepare, coordinate, and review CMC and GMP submissions to regulatory authorities
• Represent CMC Regulatory Affairs in cross-functional project teams
• Support health authority CMC meetings and mock sessions
• Participate in monthly global CMC GRT meetings
• Collaborate with manufacturing, quality, and external partners on CMC issues
• Build and maintain relationships with global functional units and suppliers
• Draft departmental job procedures
• Propose improvements to CMC regulatory processes

Skills

Strategic thinking

Analytical problem solving

Negotiation

Collaborative communication

Leadership in meetings

Regulatory information systems

Regulatory affairs knowledge

Microsoft Office (Word/Excel/PowerPt/©

Education

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

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our remote team. The role centers on providing CMC regulatory strategy input for biologic and small molecule products, focusing on the US, EU, and Canada.

You will craft and review CMC and GMP documentation, participate in health authority interactions, and collaborate across manufacturing, quality, and global partners. You will work in a fast-paced environment that emphasizes high-quality submissions and continuous