Remote Regulatory Affairs Consultant, CMC - Biologics

Parexel; Salem (OR); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings A/c

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team remotely. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products with primary responsibility for US, EU, and Canada, supporting timely approvals.

You will prepare CMC and GMP documentation, interact with cross-functional teams, and contribute to regulatory strategy from development through post-approval changes in a fast-paced, global

Qualifications

• Pharmacists degree or Pharm.D. required.
• 4–6 years CMC experience in pharma.
• Knowledge of GMP and drug development lifecycle.
• Experience preparing CMC sections for FDA/EMA submissions.
• Global regulatory environment knowledge.

Responsibilities

• Prepare and review CMC/GMP submissions for health authorities.
• Coordinate regulatory strategy with cross-functional teams.
• Lead in meetings and regulatory discussions on CMC topics.
• Develop and maintain regulatory documentation.
• Support health authority interactions and CMC meetings.

Skills

Strategic thinking

Analytical problem solving

Negotiation

Cross-functional collaboration

Communication skills

Education

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

Tools

TrackWise Digital

TRS Viewer

MS Office Suite

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join our team remotely. You will provide CMC regulatory strategy input for investigational, new, and marketed biologic and small molecule products with primary responsibility for US, EU, and Canada, supporting timely approvals.

You will prepare CMC and GMP documentation, interact with cross-functional teams, and contribute to regulatory strategy from development through post-approval changes in a fast-paced, global