Remote Regulatory Affairs Consultant – CMC for Biologics

Parexel; Oregon; Hybrid; USD 110,000 - 170,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation & Holidays

401(k) with Company Match

Pet Insurance

Flexible Spending & Health Savings

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC - Biologics to provide regulatory strategy input for biologic and small molecule products. The role focuses on global submissions and compliance across US, EU and Canada in a remote capacity. Collaboration with manufacturing, quality, and other partners is essential.

The position emphasizes strategic CMC leadership, experience in regulated pharma environments, and the ability to manage multiple projects in a matrix setting.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences or Chemistry, or Pharm.D.
• 4–6 years of CMC experience in the pharmaceutical industry.
• Knowledge of CMC regulatory requirements for biologics and small molecules.

Responsibilities

• Develop CMC regulatory strategies for biologics and small molecule products.
• Prepare and review CMC and GMP-related submissions for health authorities.
• Represent CMC Regulatory Affairs in project teams and meetings.
• Collaborate with global regulatory leads and cross-functional teams.

Skills

Strategic thinking

Analytical thinking

Negotiation

Collaboration

Communication

Presentation skills

Matrix environment

Education

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

Master's/Ph.D. in Pharmaceutics or Biology

Regulatory Affairs Certification (RAC)

Tools

TrackWise Digital

TRS Viewer

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC - Biologics to provide regulatory strategy input for biologic and small molecule products. The role focuses on global submissions and compliance across US, EU and Canada in a remote capacity. Collaboration with manufacturing, quality, and other partners is essential.

The position emphasizes strategic CMC leadership, experience in regulated pharma environments, and the ability to manage multiple projects in a matrix setting.