Remote CMC Regulatory Affairs Consultant – Biologics

Parexel; Juneau (AK); Remote; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join a remote-capable team supporting US, EU, and Canada. Lead regulatory strategy for biologics and small molecules and prepare CMC/GMP documentation for health authorities.

You will collaborate with manufacturing, quality, and external partners, contribute to project teams, and support global regulatory submissions from development through post-approval changes.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences or Chemistry (or Pharm.D.).
• 4–6 years of CMC experience in the pharmaceutical industry, with history of regulatory filing documentation.
• Knowledge of GMP, drug development, and global regulatory requirements.
• Experience preparing CMC sections for IND/NDA/DMF and submissions for FDA/Europe/Canada.
• Strong communication, negotiation, and project management skills.

Responsibilities

• Develop and implement CMC regulatory strategies for biologics and small molecules.
• Prepare and review CMC/GMP submissions for health authorities.
• Represent CMC Regulatory Affairs in project teams and cross-functional meetings.
• Support health authority meetings and monthly CMC GRT sessions.
• Build relationships with manufacturing, QA, and external partners.

Skills

Analytical thinking

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Education

Bachelor's degree in Pharmaceutical Sciences or Chemistry

Tools

TrackWise Digital

TRS Viewer

Microsoft Office

Job description

Parexel is seeking a Regulatory Affairs Consultant, CMC – Biologics to join a remote-capable team supporting US, EU, and Canada. Lead regulatory strategy for biologics and small molecules and prepare CMC/GMP documentation for health authorities.

You will collaborate with manufacturing, quality, and external partners, contribute to project teams, and support global regulatory submissions from development through post-approval changes.