Remote CMC Regulatory Affairs Consultant - Biologics

Parexel; Phoenix (AZ); À distance; USD 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Résumé du poste

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input and oversee submissions for biologics and small molecule products across US, EU, and Canada.

The role involves preparing CMC and GMP documentation, working with cross-functional teams, and supporting global regulatory meetings to drive timely approvals and continuous improvement. A strong regulatory background is essential.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharm.D.
• 4–6 years CMC experience with regulatory filings
• Knowledge of GMP and the drug development process
• Experience with FDA/EMA/Canada submissions and global regulatory environment

Responsabilités

• Develop CMC regulatory strategies for biologics and small molecules
• Prepare and review CMC & GMP documents for regulatory submissions
• Coordinate with cross-functional teams and global regulatory leads
• Represent CMC in project team meetings and health authorities
• Support monthly CMC GRT meetings with global teams
• Collaborate with manufacturing, QA, and suppliers on CMC issues
• Develop departmental procedures and drive process improvements
• Assist in health authority meetings and mock meetings

Connaissances

Strategic thinking

Analytical skills

Negotiation

Cross-functional collaboration

Regulatory expertise

Project management

Documentation & submissions

Attention to detail

Prioritization

Matrixed environment

Formation

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Pharm.D.

Master's or Ph.D. (preferred)

Outils

Trackwise Digital

TRS Viewer

Microsoft Word

Excel

PowerPoint

Outlook

Description du poste

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team in a remote capacity. You will provide CMC regulatory strategy input and oversee submissions for biologics and small molecule products across US, EU, and Canada.

The role involves preparing CMC and GMP documentation, working with cross-functional teams, and supporting global regulatory meetings to drive timely approvals and continuous improvement. A strong regulatory background is essential.