Senior CMC Regulatory Strategist - Biologics (Remote)

Parexel; Cheyenne (WY); Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

401(k) Match

Paid Time Off

Job summary

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics for a remote role. You will support regulatory strategy and compliance across investigational, new, and marketed products, coordinating with FDA, EMA, and Health Canada.

The position emphasizes CMC development, GMP compliance, and timely submissions within a fast-paced team. You will work with manufacturing, quality, and project management teams worldwide, developing strategies and ensuring regulatory alignment throughout

Qualifications

• 7+ years of CMC experience with regulatory filing documentation.
• Knowledge of biologics and small molecules in development and post-approval.
• Experience preparing CMC sections for IND/NDA/DMF submissions (FDA/Europe/Canada).
• Strong analytical, organizational, and negotiation skills.
• Proficiency with MS Office applications.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecule products.
• Prepare regulatory submissions and ensure GMP compliance.
• Collaborate with manufacturing, quality, and project teams globally.
• Represent CMC in meetings and provide regulatory guidance to teams.
• Support health authority interactions and post-approval changes.

Skills

Regulatory affairs

CMC

Biologics

FDA submissions

GMP compliance

Education

Bachelor's degree in Pharmaceutical Sciences, Chemistry, or Pharmacy (PharmD)

Tools

CREDO

ORIOM

Trackwise Digital

TRS Viewer

Job description

Parexel is seeking a Senior Regulatory Affairs Consultant – CMC Biologics for a remote role. You will support regulatory strategy and compliance across investigational, new, and marketed products, coordinating with FDA, EMA, and Health Canada.

The position emphasizes CMC development, GMP compliance, and timely submissions within a fast-paced team. You will work with manufacturing, quality, and project management teams worldwide, developing strategies and ensuring regulatory alignment throughout