Remote CMC Regulatory Affairs Consultant for Biologics

Parexel; Nashville (TN); Remote; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health benefits

Tuition reimbursement

Paid time off

Flexible spending accounts

Work-life balance

401(k) match

Pet insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote-capacity role focused on global regulatory strategy for biologics and small molecules. The role centers on US, EU, and Canada submissions, with collaboration across manufacturing, quality, and regulatory teams.

You will prepare and review CMC/GMP submissions, support health authority interactions, and contribute to process improvements within a fast-paced, global environment that advances safe

Qualifications

• Bachelor's degree in Pharmaceutical Sciences or Chemistry, or a Pharm.D.
• 4-6 years of CMC experience in the pharmaceutical industry, with regulatory filing experience
• Comprehensive knowledge of the drug development process, GMP, 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 submissions (FDA and Europe/Canada)
• Understanding of the global regulatory environment
• 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 submissions.
• Prepare, coordinate, and review CMC and GMP documents for regulatory submissions.
• Represent CMC Regulatory Affairs in cross-functional project teams.
• Prepare for health authority CMC meetings, including mock meetings.
• Support monthly CMC GRT meetings with global teams.
• Interact with manufacturing and quality groups and external partners.
• Develop and maintain relationships with local and global units; draft departmental procedures.
• Assess and develop ideas to optimize CMC regulatory processes.

Skills

Strategic thinking

Analytical skills

Negotiation

Communication skills

Team collaboration

Regulatory knowledge

Education

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

Master's or Ph.D. (preferred)

Regulatory Affairs Certification (RAC) (preferred)

Tools

Trackwise Digital

TRS Viewer

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote-capacity role focused on global regulatory strategy for biologics and small molecules. The role centers on US, EU, and Canada submissions, with collaboration across manufacturing, quality, and regulatory teams.

You will prepare and review CMC/GMP submissions, support health authority interactions, and contribute to process improvements within a fast-paced, global environment that advances safe